§ 862.3900 21 CFR Ch. I (4–1–01 Edition)

theophylline (a drug used for stimula- 864.9 Limitations of exemptions from sec- tion of the muscles in the cardio- tion 510(k) of the Federal Food, Drug, vascular, respiratory, and central nerv- and Cosmetic Act (the act). ous systems) in serum and plasma. Subpart B—Biological Stains Measurements obtained by this device are used in the diagnosis and treat- 864.1850 Dye and chemical solution stains. ment of theophylline overdose or in 864.1860 Immunohistochemistry reagents monitoring levels of theophylline to and kits. ensure appropriate therapy. Subpart C—Cell and Tissue Culture (b) Classification. Class II. Products § 862.3900 Tobramycin test system. 864.2220 Synthetic cell and tissue culture (a) Identification. A tobramycin test media and components. system is a device intended to measure 864.2240 Cell and tissue culture supplies and equipment. tobramycin, an aminoglycoside anti- 864.2260 Chromosome culture kit. biotic drug, in plasma and serum. 864.2280 Cultured animal and human cells. Measurements obtained by this device 864.2360 Mycoplasma detection media and are used in the diagnosis and treat- components. ment of tobramycin overdose and in 864.2800 Animal and human sera. monitoring levels of tobramycin to en- 864.2875 Balanced salt solutions or formula- sure appropriate therapy. tions. (b) Classification. Class II. Subpart D—Pathology Instrumentation and Accessories § 862.3910 Tricyclic antidepressant drugs test system. 864.3010 Tissue processing equipment. (a) Identification. A tricyclic 864.3250 Specimen transport and storage antidepressant drugs test system is a container. 864.3260 OTC test sample collection systems device intended to measure any of the for drugs of abuse testing. tricyclic antidepressant drugs in 864.3300 Cytocentrifuge. serum. The tricyclic antidepressant 864.3400 Device for sealing microsections. drugs include imipramine, 864.3600 Microscopes and accessories. desipramine, amitriptyline, 864.3800 Automated slide stainer. nortriptyline, protriptyline, and 864.3875 Automated tissue processor. doxepin. Measurements obtained by Subpart E—Specimen Preparation this device are used in the diagnosis Reagents and treatment of chronic depression to ensure appropriate therapy. 864.4010 General purpose reagent. (b) Classification. Class II. 864.4020 Analyte specific reagents. 864.4400 Enzyme preparations. § 862.3950 Vancomycin test system. Subpart F—Automated and Semi- (a) Identification. A vancomycin test Automated Hematology Devices system is a device intended to measure vancomycin, an antibiotic drug, in 864.5200 Automated cell counter. serum. Measurements obtained by this 864.5220 Automated differential cell device are used in the diagnosis and counter. 864.5240 Automated blood cell diluting appa- treatment of vancomycin overdose and ratus. in monitoring the level of vancomycin 864.5260 Automated cell-locating device. to ensure appropriate therapy. 864.5300 Red cell indices device. (b) Classification. Class II. 864.5350 Microsedimentation centrifuge. 864.5400 Coagulation instrument. 864.5425 Multipurpose system for in vitro PART 864—HEMATOLOGY AND coagulation studies. PATHOLOGY DEVICES 864.5600 Automated hematocrit instrument. 864.5620 Automated hemoglobin system. Subpart A—General Provisions 864.5680 Automated heparin analyzer. 864.5700 Automated platelet aggregation Sec. system. 864.1 Scope. 864.5800 Automated sedimentation rate de- 864.3 Effective dates of requirement for pre- vice. market approval. 864.5850 Automated slide spinner.

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864.5950 Blood volume measuring device. 864.8200 Blood cell diluent. 864.8500 Lymphocyte separation medium. Subpart G—Manual Hematology Devices 864.8540 Red cell lysing reagent. 864.8625 Hematology quality control mix- 864.6100 Bleeding time device. ture. 864.6150 Capillary blood collection tube. 864.8950 Russell viper venom reagent. 864.6160 Manual blood cell counting device. 864.6400 Hematocrit measuring device. 864.6550 Occult blood test. Subpart J—Products Used In Establishments 864.6600 Osmotic fragility test. That Manufacture Blood and Blood 864.6650 Platelet adhesion test. Products 864.6675 Platelet aggregometer. 864.6700 Erythrocyte sedimentation rate 864.9050 Blood bank supplies. test. 864.9100 Empty container for the collection and processing of blood and blood compo- Subpart H—Hematology Kits and nents. Packages 864.9125 Vacuum-assisted blood collection system. 864.7040 Adenosine triphosphate release 864.9145 Processing system for frozen blood. assay. 864.9160 Blood group substances of 864.7060 Antithrombin III assay. nonhuman origin for in vitro diagnostic 864.7100 Red blood cell enzyme assay. use. 864.7140 Activated whole blood clotting time 864.9175 Automated blood grouping and tests. antibody test system. 864.7250 Erythropoietin assay. 864.9185 Blood grouping view box. 864.7275 Euglobulin lysis time tests. 864.9195 Blood mixing devices and blood 864.7290 Factor deficiency test. weighing devices. 864.7300 Fibrin monomer paracoagulation 864.9205 Blood and plasma warming device. test. 864.9225 Cell-freezing apparatus and re- 864.7320 Fibrinogen/fibrin degradation prod- agents for in vitro diagnostic use. ucts assay. 864.9245 Automated blood cell separator. 864.7340 Fibrinogen determination system. 864.9275 Blood bank centrifuge for in vitro 864.7360 Erythrocytic glucose-6-phosphate diagnostic use. dehydrogenase assay. 864.7375 Glutathione reductase assay. 864.9285 Automated cell-washing centrifuge for immuno-hematology. 864.7400 Hemoglobin A2 assay. 864.7415 Abnormal hemoglobin assay. 864.9300 Automated Coombs test systems. 864.7425 Carboxyhemoglobin assay. 864.9320 Copper sulfate solution for specific 864.7440 Electrophoretic hemoglobin anal- gravity determinations. ysis system. 864.9400 Stabilized enzyme solution. 864.7455 Fetal hemoglobin assay. 864.9550 Lectins and protectins. 864.7470 Glycosylated hemoglobin assay. 864.9575 Environmental chamber for storage 864.7490 Sulfhemoglobin assay. of platelet concentrate. 864.7500 Whole blood hemoglobin assays. 864.9600 Potentiating media for in vitro di- 864.7525 Heparin assay. agnostic use. 864.7660 Leukocyte alkaline phosphatase 864.9650 Quality control kit for blood bank- test. ing reagents. 864.7675 Leukocyte peroxidase test. 864.9700 Blood storage refrigerator and 864.7695 Platelet factor 4 radioimmuno- blood storage freezer. assay. 864.9750 Heat-sealing device. 864.7720 Prothrombin consumption test. 864.9875 Transfer set. 864.7735 Prothrombin-proconvertin test and thrombotest. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 864.7750 Prothrombin time test. 360j, 371. 864.7825 Sickle cell test. 864.7875 Thrombin time test. Subpart A—General Provisions 864.7900 Thromboplastin generation test. 864.7925 Partial thromboplastin time tests. § 864.1 Scope. Subpart I—Hematology Reagents (a) This part sets forth the classifica- tion of hematology and pathology de- 864.8100 Bothrops atrox reagent. vices intended for human use that are 864.8150 Calibrator for cell indices. in commercial distribution. 864.8165 Calibrator for hemoglobin or hem- atocrit measurement. (b) The identification of a device in a 864.8175 Calibrator for platelet counting. regulation in this part is not a precise 864.8185 Calibrator for red cell and white description of every device that is, or cell counting. will be, subject to the regulation. A

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manufacturer who submits a pre- tion under section 515(b) of the act re- market notification submission for a quiring premarket approval for a de- device under part 807 may not show vice, section 501(f)(1)(A) of the act ap- merely that the device is accurately plies to the device. described by the section title and iden- (b) Any new, not substantially equiv- tification provisions of a regulation in alent, device introduced into commer- this part, but shall state why the de- cial distribution on or after May 28, vice is substantially equivalent to 1976, including a device formerly mar- other devices, as required by § 807.87. keted that has been substantially al- (c) References in this part to regu- tered, is classified by statute (section latory sections of the Code of Federal 513(f) of the act) into class III without Regulations are to chapter I of title 21, any grace period and FDA must have unless otherwise noted. issued an order approving a PMA or de- claring completed a PDP for the device [52 FR 17732, May 11, 1987] before the device is commercially dis- § 864.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring com- [52 FR 17732, May 11, 1987] pleted a product development protocol (PDP) for the device. § 864.9 Limitations of exemptions from (a) Before FDA requires that a device section 510(k) of the Federal Food, commercially distributed before the Drug, and Cosmetic Act (the act). enactment date of the amendments, or The exemption from the requirement a device that has been found substan- of premarket notification (section tially equivalent to such a device, has 510(k) of the act) for a generic type of an approval under section 515 of the act class I or II device is only to the extent FDA must promulgate a regulation that the device has existing or reason- under section 515(b) of the act requir- ably foreseeable characteristics of ing such approval, except as provided commercially distributed devices with- in paragraph (b) of this section. Such a in that generic type or, in the case of regulation under section 515(b) of the in vitro diagnostic devices, only to the act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associ- after its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any after the regulation that classifies the commercially distributed class I or II device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)(2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still sub- tive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for in- lation for a device classified into class troduction into interstate commerce III in this part, the device may be com- for commercial distribution the device mercially distributed without FDA’s when: issuance of an order approving a PMA (a) The device is intended for a use or declaring completed a PDP for the different from the intended use of a le- device. If FDA promulgates a regula- gally marketed device in that generic

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type of device; e.g., the device is in- Subpart B—Biological Stains tended for a different medical purpose, or the device is intended for lay use § 864.1850 Dye and chemical solution where the former intended use was by stains. health care professionals only; (a) Identification. Dye and chemical (b) The modified device operates solution stains for medical purposes using a different fundamental sci- are mixtures of synthetic or natural entific technology than a legally mar- dyes or nondye chemicals in solutions keted device in that generic type of de- used in staining cells and tissues for di- vice; e.g., a surgical instrument cuts agnostic histopathology, tissue with a laser beam rather than cytopathology, or hematology. with a sharpened metal blade, or an in (b) Classification. Class I. These de- vices are exempt from the premarket vitro diagnostic device detects or iden- notification procedures in subpart E of tifies infectious agents by using part 807. The devices are also exempt deoxyribonucleic acid (DNA) probe or from the current good manufacturing nucleic acid hybridization technology practice regulations in part 820 of this rather than culture or immunoassay chapter, with the exception of § 820.180, technology; or with respect to general requirements (c) The device is an in vitro device concerning records, and § 820.198, with that is intended: respect to complaint files. (1) For use in the diagnosis, moni- [45 FR 60583, Sept. 12, 1980, as amended at 54 toring, or screening of neoplastic dis- FR 25044, June 12, 1989] eases with the exception of immunohistochemical devices; § 864.1860 Immunohistochemistry re- (2) For use in screening or diagnosis agents and kits. of familial or acquired genetic dis- (a) Identification. Immunohistochem- orders, including inborn errors of me- istry test systems (IHC’s) are in vitro tabolism; diagnostic devices consisting of (3) For measuring an analyte that polyclonal or monoclonal antibodies serves as a surrogate marker for labeled with directions for use and per- screening, diagnosis, or monitoring formance claims, which may be pack- life-threatening diseases such as ac- aged with ancillary reagents in kits. quired immune deficiency syndrome Their intended use is to identify, by (AIDS), chronic or active hepatitis, tu- immunological techniques, antigens in berculosis, or myocardial infarction or tissues or cytologic specimens. Similar to monitor therapy; devices intended for use with flow cytometry devices are not considered (4) For assessing the risk of cardio- IHC’s. vascular diseases; (b) Classification of (5) For use in diabetes management; immunohistochemistry devices. (1) Class I (6) For identifying or inferring the (general controls). Except as described identity of a microorganism directly in paragraphs (b)(2) and (b)(3) of this from clinical material; section, these devices are exempt from (7) For detection of antibodies to the premarket notification require- microorganisms other than ments in part 807, subpart E of this immunoglobulin G (IgG) or IgG assays chapter. This exemption applies to when the results are not qualitative, or IHC’s that provide the pathologist with are used to determine immunity, or the adjunctive diagnostic information that assay is intended for use in matrices may be incorporated into the patholo- other than serum or plasma; gist’s report, but that is not ordinarily (8) For noninvasive testing as defined reported to the clinician as an inde- in § 812.3(k) of this chapter; and pendent finding. These IHC’s are used (9) For near patient testing (point of after the primary diagnosis of tumor (neoplasm) has been made by conven- care). tional histopathology using [65 FR 2310, Jan. 14, 2000] nonimmunologic histochemical stains,

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such as hematoxylin and eosin. Exam- notification procedures in subpart E of ples of class I IHC’s are differentiation part 807 of this chapter. markers that are used as adjunctive [45 FR 60583, Sept. 12, 1980, as amended at 54 tests to subclassify tumors, such as FR 25044, June 12, 1989] keratin. (2) Class II (special control, guidance § 864.2240 Cell and tissue culture sup- document: ‘‘FDA Guidance for Submis- plies and equipment. sion of Immunohistochemistry Appli- (a) Identification. Cell and tissue cul- cations to the FDA,’’ Center for De- ture supplies and equipment are de- vices and Radiologic Health, 1998). vices that are used to examine, propa- These IHC’s are intended for the detec- gate, nourish, or grow cells and tissue tion and/or measurement of certain cultures. These include such articles as target analytes in order to provide slide culture chambers, perfusion and prognostic or predictive data that are roller apparatus, cell culture suspen- not directly confirmed by routine sion systems, and tissue culture flasks, histopathologic internal and external disks, tubes, and roller bottles. control specimens. These IHC’s provide (b) Classification. Class I. These de- the pathologist with information that vices are exempt from the premarket is ordinarily reported as independent notification procedures in subpart E of diagnostic information to the ordering part 807 of this chapter. If the devices clinician, and the claims associated are not labeled or otherwise rep- with these data are widely accepted resented as sterile, they are exempt and supported by valid scientific evi- from the current good manufacturing dence. Examples of class II IHC’s are practice regulations in part 820 of this those intended for semiquantitative chapter, with the exception of § 820.180, measurement of an analyte, such as with respect to general requirements hormone receptors in breast cancer. concerning records, and § 820.198, with (3) Class III (premarket approval). respect to complaint files. IHC’s intended for any use not de- [45 FR 60584, Sept. 12, 1980, as amended at 54 scribed in paragraphs (b)(1) or (b)(2) of FR 25044, June 12, 1989] this section. (c) Date of PMA or notice of completion § 864.2260 Chromosome culture kit. of a PDP is required. As of May 28, 1976, (a) Identification. A chromosome cul- an approval under section 515 of the ture kit is a device containing the nec- Federal Food, Drug, and Cosmetic Act essary ingredients (e.g., Minimum Es- is required for any device described in sential Media (MEM) of McCoy’s 5A paragraph (b)(3) of this section before culture media, phytohemagglutinin, this device may be commercially dis- fetal calf serum, antibiotics, and hep- tributed. See § 864.3. arin) used to culture tissues for diag- nosis of congenital chromosome abnor- [63 FR 30142, June 3, 1998] malities. (b) Classification. Class I. The device Subpart C—Cell And Tissue is exempt from the premarket notifica- Culture Products tion procedures in subpart E of part 807 of this chapter. § 864.2220 Synthetic cell and tissue culture media and components. [45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989] (a) Identification. Synthetic cell and tissue culture media and components § 864.2280 Cultured animal and human are substances that are composed en- cells. tirely of defined components (e.g., (a) Identification. Cultured animal amino acids, vitamins, inorganic salts, and human cells are in vitro cultivated etc.) that are essential for the survival cell lines from the tissue of humans or and development of cell lines of hu- other animals which are used in var- mans and other animals. ious diagnostic procedures, particu- (b) Classification. Class I. These de- larly diagnostic virology and cyto- vices are exempt from the premarket genetic studies.

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(b) Classification. Class I (general con- Subpart D—Pathology trols). The device is exempt from the Instrumentation and Accessories premarket notification procedures in subpart E of part 807 of this chapter § 864.3010 Tissue processing equip- subject to § 864.9. ment. [45 FR 60585, Sept. 12, 1980, as amended at 65 (a) Identification. Tissue processing FR 2310, Jan. 14, 2000] equipment consists of devices used to prepare human tissue specimens for di- § 864.2360 Mycoplasma detection agnostic histological examination by media and components. processing specimens through the var- ious stages of decalcifying, infiltrating, (a) Identification. Mycoplasma detec- sectioning, and mounting on micro- tion media and components are used to scope slides. detect and isolate mycoplasma (b) Classification. Class I. The device pleuropneumonia-like organisms is exempt from the premarket notifica- (PPLO), a common microbial contami- tion procedures in subpart E of part 807 nant in cell cultures. of this chapter. The device is also ex- (b) Classification. Class I. These de- empt from the current good manufac- vices are exempt from the premarket turing practice regulations in part 820 notification procedures in subpart E of of this chapter, with the exception of part 807 of this chapter. § 820.180, with respect to general re- quirements concerning records, and [45 FR 60586, Sept. 12, 1980, as amended at 54 § 820.198, with respect to complaint FR 25044, June 12, 1989] files. § 864.2800 Animal and human sera. [45 FR 60587, Sept. 12, 1980, as amended at 54 (a) Identification. Animal and human FR 25044, June 12, 1989] sera are biological products, obtained § 864.3250 Specimen transport and from the blood of humans or other ani- storage container. mals, that provide the necessary (a) Identification. A specimen trans- growth-promoting nutrients in a cell port and storage container, which may culture system. be empty or prefilled, is a device in- (b) Classification. Class I. The devices tended to contain biological specimens, are exempt from the premarket notifi- body waste, or body exudate during cation procedures in subpart E of part storage and transport in order that the 807 of this chapter. matter contained therein can be de- [45 FR 60586, Sept. 12, 1980, as amended at 54 stroyed or used effectively for diag- FR 25044, June 12, 1989] nostic examination. If prefilled, the de- vice contains a fixative solution or § 864.2875 Balanced salt solutions or other general purpose reagent to pre- formulations. serve the condition of a biological spec- imen added to the container. (a) Identification. A balanced salt so- (b) Classification. Class I (general con- lution or formulation is a defined mix- trols). The device is exempt from the ture of salts and glucose in a simple premarket notification procedures in medium. This device is included as a subpart E of part 807 of this chapter necessary component of most cell cul- subject to § 864.9. If the device is not la- ture systems. This media component beled or otherwise represented as ster- controls for pH, osmotic pressure, en- ile, it is exempt from the current good ergy source, and inorganic ions. manufacturing practice regulations in (b) Classification. Class I. These de- part 820 of this chapter, with the excep- vices are exempt from the premarket tion of § 820.180 of this chapter, with re- notification procedures in subpart E of spect to general requirements con- part 807 of this chapter. cerning records, and § 820.198 of this chapter, with respect to complaint [45 FR 60586, Sept. 12, 1980, as amended at 54 files. FR 25044, June 12, 1989] [54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000]

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EFFECTIVE DATE NOTE: At 65 FR 18234, Apr. 2001, the effective date was delayed until 7, 2000, § 864.3250 was amended by adding a June 8, 2001. sentence to the end of paragraph (a), effec- tive Apr. 9, 2001. At 66 FR 17359, Mar. 30, 2001, § 864.3300 Cytocentrifuge. the effective date was delayed until June 8, (a) Identification. A cytocentrifuge is 2001. For the convenience of the user, the a centrifuge used to concentrate cells added text is set forth as follows: from biological cell suspensions (e.g., § 864.3250 Specimen transport and storage cerebrospinal fluid) and to deposit containers. these cells on a glass microscope slide (a) * * * This section does not apply to for cytological examination. specimen transport and storage containers (b) Classification. Class I. The device that are intended for use as part of an over- is exempt from the premarket notifica- the-counter test sample collection system tion procedures in subpart E of part 807 for drugs of abuse testing. of this chapter. [45 FR 60588, Sept. 12, 1980, as amended at 54 * * * * * FR 25044, June 12, 1989]

§ 864.3260 OTC test sample collection § 864.3400 Device for sealing microsec- systems for drugs of abuse testing. tions. (a) Identification. An over-the-counter (a) Identification. A device for sealing (OTC) test sample collection system microsections is an automated instru- for drugs of abuse testing is a device ment used to seal stained cells and intended to: Collect biological speci- microsections for histological and mens (such as hair, urine, sweat, or sa- cytological examination. liva), outside of a medical setting and (b) Classification. Class I. The device not on order of a health care profes- is exempt from the premarket notifica- sional (e.g., in the home, insurance, tion procedures in subpart E of part 807 sports, or workplace setting); maintain of this chapter. the integrity of such specimens during [45 FR 60589, Sept. 12, 1980, as amended at 54 storage and transport in order that the FR 25044, June 12, 1989] matter contained therein can be tested in a laboratory for the presence of § 864.3600 Microscopes and acces- drugs of abuse or their metabolites; sories. and provide access to test results and (a) Identification. Microscopes and ac- counseling. This section does not apply cessories are optical instruments used to collection, transport, or laboratory to enlarge images of specimens, prep- testing of biological specimens for the arations, and cultures for medical pur- presence of drugs of abuse or their me- poses. Variations of microscopes and tabolites that is performed to develop accessories (through a change in the evidence for law enforcement purposes. light source) used for medical purposes (b) Classification. Class I (general con- include the following: trols). The device is exempt from the (1) Phase contrast microscopes, premarket notification requirements which permit visualization of in part 807, subpart E of this chapter unstained preparations by altering the subject to the limitations in § 864.9 if it phase relationship of light that passes is sold, distributed, and used in accord- around the object and through the ob- ance with the restrictions set forth in ject. § 809.40 of this chapter. If the device is (2) Fluorescense microscopes, which not labeled or otherwise represented as permit examination of specimens sterile, it is exempt from the current stained with fluorochromes that fluo- good manufacturing practice regula- resce under ultraviolet light. tions in part 820 of this chapter, with (3) Inverted stage microscopes, which the exception of § 820.198 of this chapter permit examination of tissue cultures with respect to complaint files. or other biological specimens con- tained in bottles or tubes with the [65 FR 18234, Apr. 7, 2000] light source mounted above the speci- EFFECTIVE DATE NOTE: At 65 FR 18234, Apr. men. 7, 2000, § 864.3260 was added to subpart D, ef- (b) Classification. Class I. These de- fective Apr. 9, 2001. At 66 FR 17359, Mar. 30, vices are exempt from the premarket

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notification procedures in subpart E of priate for combining with one or more part 807 of this chapter. The devices are than one ASR in producing such sys- also exempt from the current good tems and include labware or disposable manufacturing practice regulations in constituents of tests; but they do not part 820 of this chapter, with the excep- include laboratory machinery, auto- tion of § 820.180, with respect to general mated or powered systems. General requirements concerning records, and purpose reagents include cytological § 820.198, with respect to complaint preservatives, decalcifying reagents, files. fixative and adhesives, tissue proc- essing reagents, isotonic solutions and [45 FR 60590, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989] pH buffers. Reagents used in tests for more than one individual chemical sub- § 864.3800 Automated slide stainer. stance or ligand are general purpose re- (a) Identification. An automated slide agents (e.g., Thermus aquaticus (TAQ) stainer is a device used to stain his- polymerase, substrates for enzyme tology, cytology, and hematology immunoassay (EIA)). slides for diagnosis. (b) Classification. Class I. The device (b) Classification. Class I. The device is exempt from the premarket notifica- is exempt from the premarket notifica- tion procedures in subpart E of part 807 tion procedures in subpart E of part 807 of this chapter. If the device is not la- of this chapter. beled or otherwise represented as ster- ile, it is exempt from the current good [45 FR 60591, Sept. 12, 1980, as amended at 54 manufacturing practice regulations in FR 25044, June 12, 1989] part 820 of this chapter, with the excep- tion of § 820.180, with respect to general § 864.3875 Automated tissue processor. requirements concerning records, and (a) Identification. An automated tis- § 820.198, with respect to complaint sue processor is an automated system files. used to process tissue specimens for ex- amination through fixation, dehydra- [45 FR 60592, Sept. 12, 1980, as amended at 54 tion, and infiltration. FR 25045, June 12, 1989; 62 FR 62260, Nov. 21, 1997] (b) Classification. Class I. The device is exempt from the premarket notifica- § 864.4020 Analyte specific reagents. tion procedures in subpart E of part 807 of this chapter. (a) Identification. Analyte specific re- agents (ASR’s) are antibodies, both [45 FR 60591, Sept. 12, 1980, as amended at 54 polyclonal and monoclonal, specific re- FR 25045, June 12, 1989] ceptor proteins, ligands, nucleic acid sequences, and similar reagents which, Subpart E—Specimen Preparation through specific binding or chemical Reagents reaction with substances in a speci- men, are intended for use in a diag- § 864.4010 General purpose reagent. nostic application for identification (a) A general purpose reagent is a and quantification of an individual chemical reagent that has general lab- chemical substance or ligand in bio- oratory application, that is used to col- logical specimens. ASR’s that other- lect, prepare, and examine specimens wise fall within this definition are not from the human body for diagnostic within the scope of subpart E of this purposes, and that is not labeled or part when they are sold to: otherwise intended for a specific diag- (1) In vitro diagnostic manufacturers; nostic application. It may be either an or individual substance, or multiple sub- (2) Organizations that use the re- stances reformulated, which, when agents to make tests for purposes other combined with or used in conjunction than providing diagnostic information with an appropriate analyte specific re- to patients and practitioners, e.g., fo- agent (ASR) and other general purpose rensic, academic, research, and other reagents, is part of a diagnostic test nonclinical laboratories. procedure or system constituting a fin- (b) Classification. (1) Class I (general ished in vitro diagnostic (IVD) test. controls). Except as described in para- General purpose reagents are appro- graphs (b)(2) and (b)(3) of this section,

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these devices are exempt from the pre- the device described in paragraph (b)(3) market notification requirements in of this section. See § 864.3. part 807, subpart E of this chapter. (2) For postamendments ASR’s; No- (2) Class II (special controls/guidance vember 23, 1998. documents), when the analyte is used (d) Restrictions. Restrictions on the in blood banking tests that have been sale, distribution and use of ASR’s are classified as class II devices (e.g., cer- set forth in § 809.30 of this chapter. tain cytomegalovirus serological and treponema pallidum nontreponemal [62 FR 62260, Nov. 21, 1997] test reagents). Guidance Documents: § 864.4400 Enzyme preparations. 1. ‘‘Specifications for Immunological Test- ing for Infectious Disease; Approved Guide- (a) Identification. Enzyme prepara- line,’’ NCCLS Document I/LA18–A, December tions are products that are used in the 1994. histopathology laboratory for the fol- 2. ‘‘Assessment of the Clinical Accuracy of lowing purposes: Laboratory Tests Using Receiver Operating (1) To disaggregate tissues and cells Characteristic (ROC) Plots; Tentative Guide- already in established cultures for line,’’ NCCLS Document KGP10–T, December 1993. preparation into subsequent cultures 3. ‘‘Review Criteria for Assessment of In (e.g., trypsin); Vitro Diagnostic Devices for Direct Detec- (2) To disaggregate fluid specimens tion of Mycobacterium spp,’’ FDA, July 6, for cytological examination (e.g., 1993, and its ‘‘Attachment 1,’’ February 28, papain for gastric lavage or trypsin for 1994. sputum liquefaction); 4. ‘‘Draft Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic De- (3) To aid in the selective staining of vices for Direct Detection of Infectious tissue specimens (e.g., diastase for gly- Microorganisms,’’ FDA, July 6, 1993. cogen determination). 5. The Center for Biologics Evaluation and (b) Classification. Class I. These de- Research, FDA, ‘‘Points to Consider in the vices are exempt from the premarket Manufacture and Clinical Evaluation of In notification procedures in subpart E of Vitro Tests to Detect Antibodies to the part 807 of this chapter. Human Immunodeficiency Virus, Type I’’ (54 FR 48943, November 28, 1989). [45 FR 60592, Sept. 12, 1980, as amended at 54 (3) Class III (premarket approval), FR 25045, June 12, 1989] when: (i) The analyte is intended as a com- Subpart F—Automated and Semi- ponent in a test intended for use in the Automated Hematology Devices diagnosis of a contagious condition that is highly likely to result in a fatal § 864.5200 Automated cell counter. outcome and prompt, accurate diag- (a) Identification. An automated cell nosis offers the opportunity to miti- counter is a fully-automated or semi- gate the public health impact of the automated device used to count red condition (e.g., human immuno- blood cells, white blood cells, or blood deficiency virus (HIV/AIDS)or tuber- platelets using a sample of the pa- culosis (TB)); or tient’s peripheral blood (blood circu- (ii) The analyte is intended as a com- lating in one of the body’s extremities, ponent in a test intended for use in such as the arm). These devices may donor screening for conditions for also measure hemoglobin or hemato- which FDA has recommended or re- crit and may also calculate or measure quired testing in order to safeguard the one or more of the red cell indices (the blood supply or establish the safe use erythrocyte mean corpuscular volume, of blood and blood products (e.g., tests the mean corpuscular hemoglobin, or for hepatitis or tests for identifying the mean corpuscular hemoglobin con- blood groups). centration). These devices may use ei- (c) Date of 510(k), or date of PMA or ther an electronic particle counting notice of completion of a product develop- method or an optical counting method. ment protocol is required. (1) (b) Classification. Class II (perform- Preamendments ASR’s; No effective ance standards). date has been established for the re- quirement for premarket approval for [45 FR 60593, Sept. 12, 1980]

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§ 864.5220 Automated differential cell globin (MCH), and the mean corpus- counter. cular hemoglobin concentration (a) Identification. An automated dif- (MCHC). The red cell indices are used ferential cell counter is a device used for the differential diagnosis of to identify and classify one or more of anemias. the formed elements of the blood. (b) Classification. Class II (perform- (b) Classification. (1) Class II (per- ance standards). formance standards) when the device is [45 FR 60597, Sept. 12, 1980] intended to flag or identify specimens containing abnormal blood cells. § 864.5350 Microsedimentation cen- (2) Class III (premarket approval) trifuge. when the device is intended for other uses, including to count or classify ab- (a) Identification. A microsedimenta- normal cells of the blood. tion centrifuge is a device used to sedi- (c) Date PMA or notice of completion of ment red cells for the microsedimenta- a PDP is required. No effective date has tion rate test. been established of the requirement for (b) Classification. Class I. The device premarket approval for the device is exempt from the premarket notifica- identified in paragraph (b)(2) of this tion procedures in subpart E of part 807 section. See § 864.3. of this chapter. [45 FR 60596, Sept. 12, 1980, as amended at 55 [45 FR 60598, Sept. 12, 1980, as amended at 59 FR 23511, June 8, 1990] FR 63007, Dec. 7, 1994]

§ 864.5240 Automated blood cell dilut- § 864.5400 Coagulation instrument. ing apparatus. (a) Identification. A coagulation in- (a) Identification. An automated blood strument is an automated or semiauto- cell diluting apparatus is a fully auto- mated device used to determine the mated or semi-automated device used onset of clot formation for in vitro co- to make appropriate dilutions of a agulation studies. blood sample for further testing. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the premarket notification procedures in [45 FR 60598, Sept. 12, 1980] subpart E of part 807 of this chapter subject to § 864.9. § 864.5425 Multipurpose system for in vitro coagulation studies. [45 FR 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] (a) Identification. A multipurpose sys- tem for in vitro coagulation studies is § 864.5260 Automated cell-locating de- a device consisting of one automated or vice. semiautomated instrument and its as- (a) Identification. An automated cell- sociated reagents and controls. The locating device is a device used to lo- system is used to perform a series of cate blood cells on a peripheral blood coagulation studies and coagulation smear, allowing the operator to iden- factor assays. tify and classify each cell according to (b) Classification. Class II (perform- type. (Peripheral blood is blood circu- ance standards). lating in one of the body’s extremities, [45 FR 60599, Sept. 12, 1980] such as the arm.) (b) Classification. Class II (perform- § 864.5600 Automated hematocrit in- ance standards). strument. [45 FR 60597, Sept. 12, 1980] (a) Identification. An automated hem- atocrit instrument is a fully auto- § 864.5300 Red cell indices device. mated or semi-automated device which (a) Identification. A red cell indices may or may not be part of a larger sys- device, usually part of a larger system, tem. This device measures the packed calculates or directly measures the red cell volume of a blood sample to erythrocyte mean corpuscular volume distinguish normal from abnormal (MCV), the mean corpuscular hemo- states, such as anemia and

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erythrocytosis (an increase in the num- mentation rate indicates tissue dam- ber of red cells). age or inflammation, the erythrocyte (b) Classification. Class II (perform- sedimentation rate device is useful in ance standards). monitoring treatment of a disease. [45 FR 60600, Sept. 12, 1980] (b) Classification. Class I. The device is exempt from the premarket notifica- § 864.5620 Automated hemoglobin sys- tion procedures in subpart E of part 807 tem. of this chapter. (a) Identification. An automated he- [45 FR 60602, Sept. 12, 1980, as amended at 54 moglobin system is a fully automated FR 25045, June 12, 1989] or semi-automated device which may or may not be part of a larger system. § 864.5850 Automated slide spinner. The generic type of device consists of (a) Identification. An automated slide the reagents, calibrators, controls, and spinner is a device that prepares auto- instrumentation used to determine the matically a blood film on a microscope hemoglobin content of human blood. slide using a small amount of periph- (b) Classification. Class II (perform- eral blood (blood circulating in one of ance standards). the body’s extremities, such as the [45 FR 60601, Sept. 12, 1980] arm). (b) Classification. Class I. The device § 864.5680 Automated heparin ana- is exempt from the premarket notifica- lyzer. tion procedures in subpart E of part 807 (a) Identification. An automated hep- of this chapter. arin analyzer is a device used to deter- [45 FR 60603, Sept. 12, 1980, as amended at 54 mine the heparin level in a blood sam- FR 25045, June 12, 1989] ple by mixing the sample with prot- amine (a heparin-neutralizing sub- § 864.5950 Blood volume measuring de- stance) and determining vice. photometrically the onset of air-acti- (a) Identification. A blood volume vated clotting. The analyzer also deter- measuring device is a manual, semi- mines the amount of protamine nec- automated, or automated system that essary to neutralize the heparin in the is used to calculate the red cell mass, patient’s circulation. plasma volume, and total blood vol- (b) Classification. Class II (special ume. controls). (b) Classification. Class II (perform- [45 FR 60601, Sept. 12, 1980, as amended at 52 ance standards). FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, [45 FR 60603, Sept. 12, 1980] 1993]

§ 864.5700 Automated platelet aggrega- Subpart G—Manual Hematology tion system. Devices (a) Identification. An automated platelet aggregation system is a device § 864.6100 Bleeding time device. used to determine changes in platelet (a) Identification. A bleeding time de- shape and platelet aggregation fol- vice is a device, usually employing two lowing the addition of an aggregating spring-loaded blades, that produces two reagent to a platelet-rich plasma. small incisions in the patient’s skin. (b) Classification. Class II (perform- The length of time required for the ance standards). bleeding to stop is a measure of the ef- [45 FR 60602, Sept. 12, 1980] fectiveness of the coagulation system, primarily the platelets. § 864.5800 Automated sedimentation (b) Classification. Class II (special rate device. controls). The device is exempt from (a) Identification. An automated sedi- the premarket notification procedures mentation rate device is an instrument in subpart E of part 807 of this chapter that measures automatically the subject to § 864.9. erythrocyte sedimentation rate in [45 FR 60604, Sept. 12, 1980, as amended at 63 whole blood. Because an increased sedi- FR 59225, Nov. 3, 1998]

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§ 864.6150 Capillary blood collection of suspected material, or by micro- tube. scopic or spectroscopic examination.) (a) Identification. A capillary blood (b) Classification. Class II (perform- collection tube is a plain or ance standards). heparinized glass tube of very small di- [45 FR 60606, Sept. 12, 1980] ameter used to collect blood by cap- illary action. § 864.6600 Osmotic fragility test. (b) Classification. Class I (general con- (a) Identification. An osmotic fragility trols). The device is exempt from the test is a device used to determine the premarket notification procedures in resistance of red blood cells to hemol- subpart E of part 807 of this chapter ysis (destruction) in varying con- subject to § 864.9. centrations of hypotonic saline solu- [45 FR 60604, Sept. 12, 1980, as amended at 54 tions. FR 25045, June 12, 1989; 65 FR 2310, Jan. 14, (b) Classification. Class I. The device 2000] is exempt from the premarket notifica- tion procedures in subpart E of part 807 § 864.6160 Manual blood cell counting device. of this chapter. (a) Identification. A manual blood cell [45 FR 60607, Sept. 12, 1980, as amended at 54 counting device is a device used to FR 25045, June 12, 1989] count red blood cells, white blood cells, or blood platelets. § 864.6650 Platelet adhesion test. (b) Classification. Class I. The device (a) Identification. A platelet adhesion is exempt from the premarket notifica- test is a device used to determine in tion procedures in subpart E of part 807 vitro platelet function. of this chapter. (b) Classification. Class II (perform- ance standards). [45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989] [45 FR 60608, Sept. 12, 1980]

§ 864.6400 Hematocrit measuring de- § 864.6675 Platelet aggregometer. vice. (a) Identification. A platelet (a) Identification. A hematocrit meas- aggregometer is a device, used to de- uring device is a system consisting of termine changes in platelet shape and instruments, tubes, racks, and a sealer platelet aggregation following the ad- and a holder. The device is used to dition of an aggregating reagent to a measure the packed red cell volume in platelet rich plasma. blood to determine whether the pa- (b) Classification. Class II (perform- tient’s total red cell volume is normal ance standards). or abnormal. Abnormal states include anemia (an abnormally low total red [45 FR 60608, Sept. 12, 1980] cell volume) and erythrocytosis (an ab- normally high total red cell mass). The § 864.6700 Erythrocyte sedimentation packed red cell volume is produced by rate test. centrifuging a given volume of blood. (a) Identification. An erythrocyte (b) Classification. Class II (special sedimentation rate test is a device that controls). The device is exempt from measures the length of time required the premarket notification procedures for the red cells in a blood sample to in subpart E of part 807 of this chapter fall a specified distance or a device subject to § 864.9. that measures the degree of sedimenta- tion taking place in a given length of [45 FR 60606, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998] time. An increased rate indicates tis- sue damage or inflammation. § 864.6550 Occult blood test. (b) Classification. Class I. The device (a) Identification. An occult blood test is exempt from the premarket notifica- is a device used to detect occult blood tion procedures in subpart E of part 807 in urine or feces. (Occult blood is blood of this chapter. present in such small quantities that it [45 FR 60608, Sept. 12, 1980, as amended at 54 can be detected only by chemical tests FR 25045, June 12, 1989]

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Subpart H—Hematology Kits and the treatment of venous thrombosis or Packages pulmonary embolism by measuring the coagulation time of whole blood. § 864.7040 Adenosine triphosphate re- (b) Classification. Class II (perform- lease assay. ance standards). (a) Identification. An adenosine [45 FR 60611, Sept. 12, 1980] triphosphate release assay is a device that measures the release of adenosine § 864.7250 Erythropoietin assay. triphosphate (ATP) from platelets fol- (a) Identification. A erythropoietin lowing aggregation. This measurement assay is a device that measures the is made on platelet-rich plasma using a concentration of erythropoietin (an en- photometer and a luminescent firefly zyme that regulates the production of extract. Simultaneous measurements red blood cells) in serum or urine. This of platelet aggregation and ATP re- assay provides diagnostic information lease are used to evaluate platelet for the evaluation of erythrocytosis function disorders. (increased total red cell mass) and ane- (b) Classification. Class I (general mia. controls). (b) Classification. Class II. The special [45 FR 60609, Sept. 12, 1980] control for this device is FDA’s ‘‘Docu- ment for Special Controls for Erythro- § 864.7060 Antithrombin III assay. poietin Assay Premarket Notification (a) Identification. An antithrombin III (510(k)s).’’ assay is a device that is used to deter- [45 FR 60612, Sept. 12, 1980, as amended at 52 mine the plasma level of antithrombin FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, III (a substance which acts with the 2000] anticoagulant heparin to prevent co- agulation). This determination is used § 864.7275 Euglobulin lysis time tests. to monitor the administration of hep- (a) Identification. A euglobulin lysis arin in the treatment of thrombosis. time test is a device that measures the The determination may also be used in length of time required for the lysis the diagnosis of thrombophilia (a con- (dissolution) of a clot formed from genital deficiency of antithrombin III). fibrinogen in the euglobulin fraction (b) Classification. Class II (perform- (that fraction of the plasma responsible ance standards). for the formation of plasmin, a clot [45 FR 60609, Sept. 12, 1980] lysing enzyme). This test evaluates natural fibrinolysis (destruction of a § 864.7100 Red blood cell enzyme blood clot after bleeding has been ar- assay. rested). The test also will detect accel- (a) Identification. Red blood cell en- erated fibrinolysis. zyme assay is a device used to measure (b) Classification. Class II (perform- the activity in red blood cells of clini- ance standards). cally important enzymatic reactions and their products, such as pyruvate [45 FR 60612, Sept. 12, 1980] kinase or 2,3-diphosphoglycerate. A red § 864.7290 Factor deficiency test. blood cell enzyme assay is used to de- termine the enzyme defects responsible (a) Identification. A factor deficiency for a patient’s hereditary hemolytic test is a device used to diagnose spe- anemia. cific coagulation defects, to monitor (b) Classification. Class II (perform- certain types of therapy, to detect co- ance standards). agulation inhibitors, and to detect a carrier state (a person carrying both a [45 FR 60610, Sept. 12, 1980] recessive gene for a coagulation factor § 864.7140 Activated whole blood clot- deficiency such as hemophilia and the ting time tests. corresponding normal gene). (b) Classification. Class II (perform- (a) Identification. An activated whole ance standards). blood clotting time tests is a device, used to monitor heparin therapy for [45 FR 60613, Sept. 12, 1980]

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§ 864.7300 Fibrin monomer § 864.7360 Erythrocytic glucose-6-phos- paracoagulation test. phate dehydrogenase assay. (a) Identification. A fibrin monomer (a) Identification. An erythrocytic paracoagulation test is a device used to glucose-6-phosphate dehydrogenase detect fibrin monomer in the diagnosis assay is a device used to measure the of disseminated intravascular coagula- activity of the enzyme glucose-6-phos- tion (nonlocalized clotting within a phate dehydrogenase or of glucose-6- blood vessel) or in the differential diag- phosphate dehydrogenase isoenzymes. nosis between disseminated The results of this assay are used in intravascular coagulation and primary the diagnosis and treatment of fibrinolysis (dissolution of the fibrin in nonspherocytic congenital hemolytic a blood clot). anemia or drug-induced hemolytic ane- mia associated with a glucose-6-phos- (b) Classification. Class II. The special phate dehydrogenase deficiency. This control for this device is FDA’s ‘‘In generic device includes assays based on Vitro Diagnostic Fibrin Monomer fluorescence, electrophoresis, Paracoagulation Test.’’ methemoglobin reduction, catalase in- [45 FR 60614, Sept. 12, 1980, as amended at 52 hibition, and ultraviolet kinetics. FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, (b) Classification. Class II (perform- 2000] ance standards).

§ 864.7320 Fibrinogen/fibrin degrada- [45 FR 60616, Sept. 12, 1980] tion products assay. § 864.7375 Glutathione reductase (a) Identification. A fibrinogen/fibrin assay. degradation products assay is a device (a) Identification. A glutathione re- used to detect and measure fibrinogen ductase assay is a device used to deter- degradation products and fibrin deg- mine the activity of the enzyme gluta- radation products (protein fragments thione reductase in serum, plasma, or produced by the enzymatic action of erythrocytes by such techniques as flu- plasmin on fibrinogen and fibrin) as an orescence and photometry. The results aid in detecting the presence and de- of this assay are used in the diagnosis gree of intravascular coagulation and of liver disease, glutathione reductase fibrinolysis (the dissolution of the deficiency, or riboflavin deficiency. fibrin in a blood clot) and in moni- (b) Classification. Class II (perform- toring therapy for disseminated ance standards). intravascular coagulation (nonlocal- ized clotting in the blood vessels). [45 FR 60616, Sept. 12, 1980] (b) Classification. Class II (perform- § 864.7400 Hemoglobin A2 assay. ance standards). (a) Identification. A hemoglobin A2 [45 FR 60615, Sept. 12, 1980] assay is a device used to determine the hemoglobin A2 content of human blood. § 864.7340 Fibrinogen determination The measurement of hemoglobin A2 is system. used in the diagnosis of the (a) Identification. A fibrinogen deter- thalassemias (hereditary hemolytic mination system is a device that con- anemias characterized by decreased sists of the instruments, reagents, synthesis of one or more types of he- standards, and controls used to deter- moglobin polypeptide chains). mine the fibrinogen levels in dissemi- (b) Classification. Class II (perform- nated intravascular coagulation (non- ance standards). localized clotting within the blood ves- [45 FR 60617, Sept. 12, 1980] sels) and primary fibrinolysis (the dis- solution of fibrin in a blood clot). § 864.7415 Abnormal hemoglobin assay. (b) Classification. Class II (perform- (a) Identification. An abnormal hemo- ance standards). globin assay is a device consisting of [45 FR 60615, Sept. 12, 1980] the reagents, apparatus, instrumenta- tion, and controls necessary to isolate

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and identify abnormal genetically de- (b) Classification. Class II (perform- termined hemoglobin types. ance standards). (b) Classification. Class II (perform- [45 FR 60620, Sept. 12, 1980] ance standards). [45 FR 60618, Sept. 12, 1980] § 864.7470 Glycosylated hemoglobin assay. § 864.7425 Carboxyhemoglobin assay. (a) Identification. A glycosylated he- (a) Identification. A carboxy- moglobin assay is a device used to hemoglobin assay is a device used to measure the glycosylated hemoglobins determine the carboxyhemoglobin (the (A1a, A1b, and A1c) in a patient’s blood compound formed when hemoglobin is by a column chromatographic proce- exposed to carbon monoxide) content of dure. Measurement of glycosylated he- human blood as an aid in the diagnosis moglobin is used to assess the level of of carbon monoxide poisoning. This control of a patient’s diabetes and to measurement may be made using determine the proper insulin dosage for methods such as spectroscopy, colorim- a patient. Elevated levels of etry, spectrophotometry, and glycosylated hemoglobin indicate un- gasometry. controlled diabetes in a patient. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60619, Sept. 12, 1980] [45 FR 60621, Sept. 12, 1980]

§ 864.7440 Electrophoretic hemoglobin § 864.7490 Sulfhemoglobin assay. analysis system. (a) Identification. A sulfhemoglobin (a) Identification. An electrophoretic assay is a device consisting of the re- hemoglobin analysis system is a device agents, calibrators, controls, and in- that electrophoretically separates and strumentation used to determine the identifies normal and abnormal hemo- sulfhemoglobin (a compound of sulfur globin types as an aid in the diagnosis and hemoglobin) content of human of anemia or erythrocytosis (increased blood as an aid in the diagnosis of total red cell mass) due to a hemo- sulfhemoglobinemia (presence of globin abnormality. sulfhemoglobin in the blood due to (b) Classification. Class II (perform- drug administration or exposure to a ance standards). poison). This measurement may be [45 FR 60620, Sept. 12, 1980] made using methods such as spectros- copy, colorimetry, spectrophotometry, § 864.7455 Fetal hemoglobin assay. or gasometry. (b) Classification. Class II (perform- (a) Identification. A fetal hemoglobin assay is a device that is used to deter- ance standards). mine the presence and distribution of [45 FR 60621, Sept. 12, 1980] fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal § 864.7500 Whole blood hemoglobin as- hemoglobin present. The assay may be says. used to detect fetal red cells in the ma- (a) Identification. A whole blood he- ternal circulation or to detect the ele- moglobin assay is a device consisting vated levels of fetal hemoglobin exhib- or reagents, calibrators, controls, or ited in cases of hemoglobin abnormali- photometric or spectrophotometric in- ties such as thalassemia (a hereditary strumentation used to measure the he- hemolytic anemia characterized by a moglobin content of whole blood for decreased synthesis of one or more the detection of anemia. This generic types of hemoglobin polypeptide device category does not include auto- chains). The hemoglobin determination mated hemoglobin systems. may be made by methods such as elec- (b) Classification. Class II (perform- trophoresis, alkali denaturation, col- ance standards). umn chromatography, or radial immunodiffusion. [45 FR 60622, Sept. 12, 1980]

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§ 864.7525 Heparin assay. tion procedures in subpart E of part 807 of this chapter. (a) Identification. A heparin assay is a device used to determine the level of [45 FR 60624, Sept. 12, 1980, as amended at 59 the anticoagulant heparin in the pa- FR 63007, Dec. 7, 1994] tient’s circulation. These assays are § 864.7695 Platelet factor 4 quantitative clotting time procedures radioimmunoassay. using the effect of heparin on activated coagulation factor X (Stuart factor) or (a) Identification. A platelet factor 4 radioimmunoassay is a device used to procedures based on the neutralization measure the level of platelet factor 4, a of heparin by protamine sulfate (a pro- protein released during platelet activa- tein that neutralizes heparin). tion by radioimmunoassay. This device (b) Classification. Class II (perform- measures platelet activiation, which ance standards). may indicate a coagulation disorder, [45 FR 60623, Sept. 12, 1980] such as myocardial infarction or coro- nary artery disease. § 864.7660 Leukocyte alkaline phos- (b) Classification. Class II (perform- phatase test. ance standards). (a) Identification. A leukocyte alka- [45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. line phosphatase test is a device used 3, 1981] to identify the enzyme leukocyte alka- line phosphatase in neutrophilic § 864.7720 Prothrombin consumption test. granulocytes (granular leukocytes stainable by neutral dyes). The (a) Identification. A prothrombin con- cytochemical identification of alkaline sumption tests is a device that meas- phosphatase depends on the formation ures the patient’s capacity to generate of blue granules in cells containing al- thromboplastin in the coagulation process. The test also is an indirect in- kaline phosphatase. The results of this dicator of qualitative or quantitative test are used to differentiate chronic platelet abnormalities. It is a screen- granulocytic leukemia (a malignant ing test for thrombocytopenia (de- disease characterized by excessive creased number of blood platelets) and overgrowth of granulocytes in the bone hemophilia A and B. marrow) and reactions that resemble (b) Classification. Class II (perform- true leukemia, such as those occuring ance standards). in severe infections and polycythemia (increased total red cell mass). [45 FR 60625, Sept. 12, 1980] (b) Classification. Class I. The device § 864.7735 Prothrombin-proconvertin is exempt from the premarket notifica- test and thrombotest. tion procedures in subpart E of part 807 (a) Identification. The prothrombin- of this chapter. proconvertin test and thrombotest are [45 FR 60623, Sept. 12, 1980, as amended at 59 devices used in the regulation of cou- FR 63007, Dec. 7, 1994] marin therapy (administration of a coumarin anticoagulant such as so- § 864.7675 Leukocyte peroxidase test. dium warfarin in the treatment of ve- (a) Identification. A leukocyte peroxi- nous thrombosis and pulmonary embo- dase test is a device used to distinguish lism) and as a diagnostic test in con- certain myeloid cells derived from the junction with, or in place of, the Quick bone marrow, i.e., neutrophils, prothrombin time test to detect coagu- eosinophils, and monocytes, from lation disorders. lymphoid cells of the lymphatic system (b) Classification. Class II (perform- and erythroid cells of the red blood cell ance standards). series on the basis of their peroxidase [45 FR 60626, Sept. 12, 1980] activity as evidenced by staining. The results of this test are used in the dif- § 864.7750 Prothrombin time test. ferential diagnosis of the leukemias. (a) Identification. A prothrombin time (b) Classification. Class I. The device test is a device used as a general is exempt from the premarket notifica- screening procedure for the detection

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of possible clotting factor deficiencies (b) Classification. Class II (perform- in the extrinsic coagulation pathway, ance standards). which involves the reaction between [45 FR 60629, Sept. 12, 1980] coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of Subpart I—Hematology Reagents the coumarin anticoagulants in the § 864.8100 Bothrops atrox reagent. treatment of venous thrombosis or pul- monary embolism). (a) Identification. A Bothrops atrox (b) Classification. Class II (perform- reagent is a device made from snake ance standards). venom and used to determine blood fibrinogen levels to aid in the evalua- [45 FR 60626, Sept. 12, 1980] tion of disseminated intravascular co- agulation (nonlocalized clotting in the § 864.7825 Sickle cell test. blood vessels) in patients receiving (a) Identification. A sickle cell test is heparin therapy (the administration of a device used to determine the sickle the anticoagulant heparin in the treat- cell hemoglobin content of human ment of thrombosis) or as an aid in the blood to detect sickle cell trait or sick- classification of dysfibrinogenemia le cell diseases. (presence in the plasma of functionally (b) Classification. Class II (perform- defective fibrinogen). ance standards). (b) Classification. Class II (perform- ance standards). [45 FR 60627, Sept. 12, 1980] [45 FR 60629, Sept. 12, 1980] § 864.7875 Thrombin time test. § 864.8150 Calibrator for cell indices. (a) Identification. A thrombin time (a) Identification. A calibrator for cell test is a device used to measure indices is a device that approximates fibrinogen concentration and detect whole blood or certain blood cells and fibrin or fibrinogen split products for that is used to set an instrument in- the evaluation of bleeding disorders. tended to measure mean cell volume (b) Classification. Class II (perform- (MCV), mean corpuscular hemoglobin ance standards). (MCH), and mean corpuscular hemo- [45 FR 60628, Sept. 12, 1980] globin concentration (MCHC), or other cell indices. It is a suspension of par- § 864.7900 Thromboplastin generation ticles or cells whose size, shape, con- test. centration, and other characteristics (a) Identification. A thromboplastin have been precisely and accurately de- generation test is a device used to de- termined. tect and identify coagulation factor de- (b) Classification. Class II (perform- ficiencies and coagulation inhibitors. ance standards). (b) Classification. Class I. The device [45 FR 60631, Sept. 12, 1980] is exempt from the premarket notifica- tion procedures in subpart E of part 807 § 864.8165 Calibrator for hemoglobin of this chapter. or hematocrit measurement. [45 FR 60628, Sept. 12, 1980, as amended at 59 (a) Identification. A calibrator for he- FR 63007, Dec. 7, 1994] moglobin or hematocrit measurement is a device that approximates whole § 864.7925 Partial thromboplastin time blood, red blood cells, or a hemoglobin tests. derivative and that is used to set in- (a) Identification. A partial thrombo- struments intended to measure hemo- plastin time test is a device used for globin, the hematocrit, or both. It is a primary screening for coagulation ab- material whose characteristics have normalities, for evaluation of the ef- been precisely and accurately deter- fect of therapy on procoagulant dis- mined. orders, and as an assay for coagulation (b) Classification. Class II (perform- factor deficiencies of the intrinsic co- ance standards). agulation pathway. [45 FR 60632, Sept. 12, 1980]

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§ 864.8175 Calibrator for platelet § 864.8540 Red cell lysing reagent. counting. (a) Identification. A red cell lysing re- (a) Identification. A calibrator for agent is a device used to lyse (destroy) platelet counting is a device that re- red blood cells for hemoglobin deter- sembles platelets in plasma or whole minations or aid in the counting of blood and that is used to set a platelet white blood cells. counting instrument. It is a suspension (b) Classification. Class I. The device of particles or cells whose size, shape is exempt from the premarket notifica- concentration, and other characteris- tion procedures in subpart E of part 807 tics have been precisely and accurately of this chapter. determined. [45 FR 60636, Sept. 12, 1980, as amended at 54 (b) Classification. Class II (perform- FR 25045, June 12, 1989] ance standards). § 864.8625 Hematology quality control [45 FR 60633, Sept. 12, 1980] mixture. § 864.8185 Calibrator for red cell and (a) Identification. A hematology qual- white cell counting. ity control mixture is a device used to ascertain the accuracy and precision of (a) Identification. A calibrator for red manual, semiautomated, and auto- cell and white cell counting is a device mated determinations of cell param- that resembles red or white blood cells eters such as white cell count (WBC), and that is used to set instruments in- red cell count (RBC), platelet count tended to count red cells, white cells, (PLT), hemoglobin, hematocrit (HCT), or both. It is a suspension of particles mean corpuscular volume (MCV), mean or cells whose size, shape, concentra- corpuscular hemoglobin (MCH), and tion, and other characteristics have mean corpuscular hemoglobin con- been precisely and accurately deter- centration (MCHC). mined. (b) Classification. Class II (perform- (b) Classification. Class II (perform- ance standards). ance standards). [45 FR 60637, Sept. 12, 1980] [45 FR 60634, Sept. 12, 1980] § 864.8950 Russell viper venom rea- § 864.8200 Blood cell diluent. gent. (a) Identification. A blood cell diluent (a) Identification. Russell viper venom is a device used to dilute blood for fur- reagent is a device used to determine ther testing, such as blood cell count- the cause of an increase in the pro- thrombin time. ing. (b) Classification. Class I (general con- (b) Classification. Class I. The device trols). is exempt from the premarket notifica- tion procedures in subpart E of part 807 [45 FR 60637, Sept. 12, 1980] of this chapter. [45 FR 60635, Sept. 12, 1980, as amended at 54 Subpart J—Products Used In Es- FR 25045, June 12, 1989] tablishments That Manufac- ture Blood and Blood Products § 864.8500 Lymphocyte separation me- dium. § 864.9050 Blood bank supplies. (a) Identification. A lymphocyte sepa- (a) Identification. Blood bank supplies ration medium is a device used to iso- are general purpose devices intended late lymphocytes from whole blood. for in vitro use in blood banking. This (b) Classification. Class I. The device generic type of device includes prod- is exempt from the premarket notifica- ucts such as blood bank pipettes, blood tion procedures in subpart E of part 807 grouping slides, blood typing tubes, of this chapter. blood typing racks, and cold packs for antisera reagents. The device does not [45 FR 60636, Sept. 12, 1980, as amended at 59 include articles that are licensed by FR 63007, Dec. 7, 1994] the Center for Biologics Evaluation

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and Research of the Food and Drug Ad- diagnostic use are materials, such as ministration. blood group specific substances pre- (b) Classification. Class I (general con- pared from nonhuman sources (e.g., trols). pigs, cows, and horses) used to detect, [45 FR 60638, Sept. 12, 1980, as amended at 53 identify, or neutralize antibodies to FR 11253, Apr. 6, 1988] various human blood group antigens. This generic type of device does not in- § 864.9100 Empty container for the col- clude materials that are licensed by lection and processing of blood and the Center for Biologics Evaluation blood components. and Research of the Food and Drug Ad- (a) Identification. An empty container ministration. for the collection and processing of (b) Classification. Class II (special blood and blood components is a device controls). The device is exempt from intended for medical purposes that is the premarket notification procedures an empty plastic bag or plastic or glass in subpart E of part 807 of this chapter bottle used to collect, store, or transfer subject to § 864.9. blood and blood components for further [45 FR 60640, Sept. 12, 1980, as amended at 53 processing. FR 11253, Apr. 6, 1988; 63 FR 59225, Nov. 3, (b) Classification. Class II (perform- 1998] ance standards). § 864.9175 Automated blood grouping [45 FR 60638, Sept. 12, 1980] and antibody test system. § 864.9125 Vacuum-assisted blood col- (a) Identification. An automated blood lection system. grouping and antibody test system is a (a) Identification. A vacuum-assisted device used to group erythrocytes (red blood collection system is a device in- blood cells) and to detect antibodies to tended for medical purposes that uses a blood group antigens. vacuum to draw blood for subsequent (b) Classification. Class II (perform- reinfusion. ance standards). (b) Classification. Class I (general con- [45 FR 60641, Sept. 12, 1980] trols). The manual device is exempt from the premarket notification proce- § 864.9185 Blood grouping view box. dures in subpart E of part 807 of this (a) Identification. A blood grouping chapter subject to § 864.9. view box is a device with a glass or [45 FR 60639, Sept. 12, 1980, as amended at 65 plastic viewing surface, which may be FR 2310, Jan. 14, 2000] illuminated and heated, that is used to view cell reactions in antigen-antibody § 864.9145 Processing system for fro- testing. zen blood. (b) Classification. Class I (general con- (a) Identification. A processing system trols). The device is exempt from the for frozen blood is a device used to premarket notification procedures in glycerolize red blood cells prior to subpart E of part 807 of this chapter freezing to minimize hemolysis (disrup- subject to § 864.9. tion of the red cell membrane accom- [45 FR 60641, Sept. 12, 1980, as amended at 65 panied by the release of hemoglobin) FR 2310, Jan. 14, 2000] due to freezing and thawing of red blood cells and to deglycerolize and § 864.9195 Blood mixing devices and wash thawed cells for subsequent re- blood weighing devices. infusion. (a) Identification. A blood mixing de- (b) Classification. Class II (perform- vice is a device intended for medical ance standards). purposes that is used to mix blood or [45 FR 60639, Sept. 12, 1980] blood components by agitation. A blood weighing device is a device in- § 864.9160 Blood group substances of tended for medical purposes that is nonhuman origin for in vitro diag- used to weigh blood or blood compo- nostic use. nents as they are collected. (a) Identification. Blood group sub- (b) Classification. Class I (general con- stances of nonhuman origin for in vitro trols). The manual device is exempt

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from the premarket notification proce- one or more of the components, and re- dures in subpart E of part 807 of this turns the remainder of the blood to the chapter subject to § 864.9. donor. The components obtained are transfused or used to prepare blood [45 FR 60642, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] products for administration. These de- vices operate on either a centrifugal § 864.9205 Blood and plasma warming separation principle or a filtration device. principle. The separation bowls of cen- (a) Nonelectromagnetic blood or plasma trifugal blood cell separators may be warming device—(1) Identification. A reusable or disposable. nonelectromagnetic blood and plasma (b) Classification. Class III (premarket warming device is a device that warms approval). blood or plasma, by means other than (c) Date PMA or notice of completion of electromagnetic radiation, prior to ad- a PDP is required. No effective date has ministration. been established of the requirement for (2) Classification. Class II (perform- premarket approval. See § 864.3. ance standards). [45 FR 60645, Sept. 12, 1980, as amended at 52 (b) Electromagnetic blood and plasma FR 17733, May 11, 1987] warming device—(1) Identification. An electromagnetic blood and plasma § 864.9275 Blood bank centrifuge for in warming device is a device that em- vitro diagnostic use. ploys electromagnetic radiation (a) Identification. A blood bank cen- (radiowaves or microwaves) to warm a trifuge for in vitro diagnostic use is a bag or bottle of blood or plasma prior device used only to separate blood cells to administration. for further diagnostic testing. (2) Classfication. Class III (premarket (b) Classification. Class I (general con- approval). trols). The device is exempt from the (c) Date PMA or notice of completion of premarket notification procedures in a PDP is required. No effective date has subpart E of part 807 of this chapter been established of the requirement for subject to § 864.9. premarket approval for the device de- scribed in paragraph (b)(1). See § 864.3. [45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] [45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987] § 864.9285 Automated cell-washing centrifuge for immuno-hematology. § 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use. (a) Identification. An automated cell- (a) Identification. Cell-freezing appa- washing centrifuge for immuno-hema- ratus and reagents for in vitro diag- tology is a device used to separate and nostic use are devices used to freeze prepare cells and sera for further in human red blood cells for in vitro diag- vitro diagnostic testing. nostic use. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the [45 FR 60646, Sept. 12, 1980] premarket notification procedures in subpart E of part 807 of this chapter § 864.9300 Automated Coombs test sys- subject to § 864.9. tems. [45 FR 60643, Sept. 12, 1980, as amended at 65 (a) Identification. An automated FR 2310, Jan. 14, 2000] Coombs test system is a device used to detect and identify antibodies in pa- § 864.9245 Automated blood cell sepa- tient sera or antibodies bound to red rator. cells. The Coombs test is used for the (a) Identification. An automated blood diagnosis of hemolytic disease of the cell separator is a device that auto- newborn, and autoimmune hemolytic matically removes whole blood from a anemia. The test is also used in donor, separates the blood into compo- crossmatching and in investigating nents (red blood cells, white blood transfusion reactions and drug-induced cells, plasma, and platelets), retains red cell sensitization.

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(b) Classification. Class II (perform- centrate is a device used to hold plate- ance standards). let-rich plasma within a preselected temperature range. [45 FR 60646, Sept. 12, 1980] (b) Classification. Class II (special § 864.9320 Copper sulfate solution for controls). The device is exempt from specific gravity determinations. the premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A copper sulfate so- subject to § 864.9. lution for specific gravity determina- tions is a device used to determine [45 FR 60648, Sept. 12, 1980, as amended at 63 whether the hemoglobin content of a FR 59226, Nov. 3, 1998] potential donor’s blood meets the re- § 864.9600 Potentiating media for in quired level (12.5 grams per 100 milli- vitro diagnostic use. liters of blood for women and 13.5 grams per 100 milliliters of blood for (a) Identification. Potentiating media men). for in vitro diagnostic use are media, (b) Classification. Class I (general con- such as bovine albumin, that are used trols). The device is exempt from the to suspend red cells and to enhance cell premarket notification procedures in reactions for antigen-antibody testing. (b) . Class II (special subpart E of part 807 of this chapter Classification controls). The device is exempt from subject to § 864.9. the premarket notification procedures [45 FR 60647, Sept. 12, 1980, as amended at 65 in subpart E of part 807 of this chapter FR 2310, Jan. 14, 2000] subject to § 864.9. § 864.9400 Stabilized enzyme solution. [45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] (a) Identification. A stabilized enzyme solution is a reagent intended for med- § 864.9650 Quality control kit for blood ical purposes that is used to enhance banking reagents. the reactivity of red blood cells with (a) Identification. A quality control certain antibodies, including anti- kit for blood banking reagents is a de- bodies that are not detectable by other vice that consists of sera, cells, buffers, techniques. These enzyme solutions in- and antibodies used to determine the clude papain, bromelin, ficin, and specificity, potency, and reactivity of trypsin. the cells and reagents used for blood (b) Classification. Class II (perform- banking. ance standards). (b) Classification. Class II (perform- [45 FR 60647, Sept. 12, 1980] ance standards). [45 FR 60649, Sept. 12, 1980] § 864.9550 Lectins and protectins. (a) Identification. Lectins and § 864.9700 Blood storage refrigerator protectins are proteins derived from and blood storage freezer. plants and lower animals that cause (a) Identification. A blood storage re- cell agglutination in the presence of frigerator and a blood storage freezer certain antigens. These substances are are devices intended for medical pur- used to detect blood group antigens for poses that are used to preserve blood in vitro diagnostic purposes. and blood products by storing them at (b) Classification. Class II (special cold or freezing temperatures. controls). The device is exempt from (b) Classification. Class II (special the premarket notification procedures controls). The device is exempt from in subpart E of part 807 of this chapter the premarket notification procedures subject to § 864.9. in subpart E of part 807 of this chapter subject to § 864.9. [45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] [45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] § 864.9575 Environmental chamber for storage of platelet concentrate. § 864.9750 Heat-sealing device. (a) Identification. An environmental (a) Identification. A heat-sealing de- chamber for storage of platelet con- vice is a device intended for medical

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purposes that uses heat to seal plastic 866.2440 Automated medium dispensing and bags containing blood or blood compo- stacking device. nents. 866.2450 Supplement for culture media. (b) Classification. Class I (general con- 866.2480 Quality control kit for culture media. trols). The device is exempt from the 866.2500 Microtiter diluting and dispensing premarket notification procedures in device. subpart E of part 807 of this chapter 866.2540 Microbiological incubator. subject to § 864.9. 866.2560 Microbial growth monitor. 866.2580 Gas-generating device. [45 FR 60650, Sept. 12, 1980, as amended at 65 866.2600 Wood’s fluorescent lamp. FR 2311, Jan. 14, 2000] 866.2660 Microorganism differentiation and identification device. § 864.9875 Transfer set. 866.2850 Automated zone reader. (a) Identification. A transfer set is a 866.2900 Microbiological specimen collection device intended for medical purposes and transport device. that consists of a piece of tubing with Subpart D—Serological Reagents suitable adaptors used to transfer blood or plasma from one container to 866.3010 Acinetobacter calcoaceticus sero- another. logical reagents. (b) Classification. Class II (perform- 866.3020 Adenovirus serological reagents. ance standards). 866.3035 Arizona spp. serological reagents. 866.3040 Aspergillus spp. serological reagents. [45 FR 60651, Sept. 12, 1980] 866.3060 Blastomyces dermatitidis serological reagents. PART 866—IMMUNOLOGY AND 866.3065 Bordetella spp. serological reagents. 866.3085 Brucella spp. serological reagents. MICROBIOLOGY DEVICES 866.3110 Campylobacter fetus serological re- agents. Subpart A—General Provisions 866.3120 Chlamydia serological reagents. 866.3125 Citrobacter spp. serological reagents. Sec. 866.3135 Coccidioides immitis serological re- 866.1 Scope. agents. 866.3 Effective dates of requirement for pre- 866.3140 Corynebacterium spp. serological re- market approval. agents. 866.9 Limitations of exemptions from sec- 866.3145 Coxsackievirus serological re- tion 510(k) of the Federal Food, Drug, agents. and Cosmetic Act (the act). 866.3165 Cryptococcus neoformans serological reagents. Subpart B—Diagnostic Devices 866.3175 Cytomegalovirus serological re- 866.1620 Antimicrobial susceptibility test agents. disc. 866.3200 Echinococcus spp. serological re- 866.1640 Antimicrobial susceptibility test agents. powder. 866.3205 Echovirus serological reagents. 866.1700 Culture medium for antimicrobial 866.3220 Entamoeba histolytica serological re- susceptibility tests. agents. 866.3235 Epstein-Barr virus serological re- Subpart C—Microbiology Devices agents. 866.3240 Equine encephalomyelitis virus se- 866.2050 Staphylococcal typing rological reagents. bacteriophage. 866.3250 Erysipelothrix rhusiopathiae sero- 866.2120 Anaerobic chamber. logical reagents. 866.2160 Coagulase plasma. 866.3255 Escherichia coli serological reagents. 866.2170 Automated colony counter. 866.3270 Flavobacterium spp. serological re- 866.2180 Manual colony counter. agents. 866.2300 Multipurpose culture medium. 866.3280 Francisella tularensis serological re- 866.2320 Differential culture medium. agents. 866.2330 Enriched culture medium. 866.3290 Gonococcal antibody test (GAT). 866.2350 Microbiological assay culture me- 866.3300 Haemophilus spp. serological re- dium. agents. 866.2360 Selective culture medium. 866.3305 Herpes simplex virus serological re- 866.2390 Transport culture medium. agents. 866.2410 Culture medium for pathogenic 866.3320 Histoplasma capsulatum serological Neisseria spp. reagents. 866.2420 Oxidase screening test for gonor- 866.3330 Influenza virus serological re- rhea. agents.

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