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21 CFR Ch. I (4–1–20 Edition)

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21 CFR Ch. I (4–1–20 Edition) § 862.3880 21 CFR Ch. I (4–1–20 Edition) cannabidiol, cannabinol, and § 862.3910 Tricyclic antidepressant cannabichromene. Measurements ob- drugs test system. tained by this device are used in the di- (a) Identification. A tricyclic agnosis and treatment of cannabinoid antidepressant drugs test system is a use or abuse and in monitoring levels device intended to measure any of the of cannabinoids during clinical inves- tricyclic antidepressant drugs in tigational use. serum. The tricyclic antidepressant (b) Classification. Class II (special drugs include imipramine, controls). A cannabinoid test system is desipramine, amitriptyline, not exempt if it is intended for any use nortriptyline, protriptyline, and other than employment or insurance doxepin. Measurements obtained by testing or is intended for Federal drug this device are used in the diagnosis testing programs. The device is exempt and treatment of chronic depression to from the premarket notification proce- ensure appropriate therapy. (b) Classification. Class II (special dures in subpart E of part 807 of this controls). A tricyclic antidepressant chapter subject to the limitations in drugs test system is not exempt if it is § 862.9, provided the test system is in- intended for any use other than em- tended for employment and insurance ployment or insurance testing or is in- testing and includes a statement in the tended for Federal drug testing pro- labeling that the device is intended grams. The device is exempt from the solely for use in employment and in- premarket notification procedures in surance testing, and does not include subpart E of part 807 of this chapter devices intended for Federal drug test- subject to the limitations in § 862.9, ing programs (e.g., programs run by the provided the test system is intended Substance Abuse and Mental Health for employment and insurance testing Services Administration (SAMHSA), and includes a statement in the label- the Department of Transportation ing that the device is intended solely (DOT), and the U.S. military). for use in employment and insurance testing, and does not include devices [52 FR 16122, May 1, 1987, as amended at 84 intended for Federal drug testing pro- FR 71799, Dec. 30, 2019] grams (e.g., programs run by the Sub- § 862.3880 Theophylline test system. stance Abuse and Mental Health Serv- ices Administration (SAMHSA), the (a) Identification. A theophylline test Department of Transportation (DOT), system is a device intended to measure and the U.S. military). theophylline (a drug used for stimula- tion of the muscles in the cardio- [52 FR 16122, May 1, 1987, as amended at 84 FR 71799, Dec. 30, 2019] vascular, respiratory, and central nerv- ous systems) in serum and plasma. § 862.3950 Vancomycin test system. Measurements obtained by this device (a) Identification. A vancomycin test are used in the diagnosis and treat- system is a device intended to measure ment of theophylline overdose or in vancomycin, an antibiotic drug, in monitoring levels of theophylline to serum. Measurements obtained by this ensure appropriate therapy. device are used in the diagnosis and (b) Classification. Class II. treatment of vancomycin overdose and in monitoring the level of vancomycin § 862.3900 Tobramycin test system. to ensure appropriate therapy. (a) Identification. A tobramycin test (b) Classification. Class II. system is a device intended to measure tobramycin, an aminoglycoside anti- PART 864—HEMATOLOGY AND biotic drug, in plasma and serum. PATHOLOGY DEVICES Measurements obtained by this device are used in the diagnosis and treat- Subpart A—General Provisions ment of tobramycin overdose and in Sec. monitoring levels of tobramycin to en- 864.1 Scope. sure appropriate therapy. 864.3 Effective dates of requirement for pre- (b) Classification. Class II. market approval. 262 VerDate Sep<11>2014 17:19 Sep 28, 2020 Jkt 250077 PO 00000 Frm 00272 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS Pt. 864 864.9 Limitations of exemptions from sec- 864.5600 Automated hematocrit instrument. tion 510(k) of the Federal Food, Drug, 864.5620 Automated hemoglobin system. and Cosmetic Act (the act). 864.5680 Automated heparin analyzer. 864.5700 Automated platelet aggregation Subpart B—Biological Stains system. 864.5800 Automated sedimentation rate de- 864.1850 Dye and chemical solution stains. vice. 864.1860 Immunohistochemistry reagents 864.5850 Automated slide spinner. and kits. 864.5950 Blood volume measuring device. 864.1865 Cervical intraepithelial neoplasia (CIN) test system. Subpart G—Manual Hematology Devices 864.1866 Lynch syndrome test systems. 864.1870 Early growth response 1 (EGR1) 864.6100 Bleeding time device. gene fluorescence in-situ hybridization 864.6150 Capillary blood collection tube. (FISH) test system for specimen charac- 864.6160 Manual blood cell counting device. terization. 864.6400 Hematocrit measuring device. 864.6550 Occult blood test. Subpart C—Cell and Tissue Culture 864.6600 Osmotic fragility test. Products 864.6650 Platelet adhesion test. 864.6675 Platelet aggregometer. 864.2220 Synthetic cell and tissue culture 864.6700 Erythrocyte sedimentation rate media and components. test. 864.2240 Cell and tissue culture supplies and equipment. Subpart H—Hematology Kits and 864.2260 Chromosome culture kit. Packages 864.2280 Cultured animal and human cells. 864.2360 Mycoplasma detection media and 864.7010 Flow cytometric test system for components. hematopoietic neoplasms. 864.2800 Animal and human sera. 864.7040 Adenosine triphosphate release 864.2875 Balanced salt solutions or formula- assay. tions. 864.7060 Antithrombin III assay. 864.7100 Red blood cell enzyme assay. Subpart D—Pathology Instrumentation and 864.7140 Activated whole blood clotting time Accessories tests. 864.7250 Erythropoietin assay. 864.3010 Tissue processing equipment. 864.7275 Euglobulin lysis time tests. 864.3250 Specimen transport and storage 864.7280 Factor V Leiden DNA mutation de- container. tection systems. 864.3260 OTC test sample collection systems 864.7290 Factor deficiency test. for drugs of abuse testing. 864.7300 Fibrin monomer paracoagulation 864.3300 Cytocentrifuge. test. 864.3400 Device for sealing microsections. 864.7320 Fibrinogen/fibrin degradation prod- 864.3600 Microscopes and accessories. ucts assay. 864.3700 Whole slide imaging system. 864.7340 Fibrinogen determination system. 864.3800 Automated slide stainer. 864.7360 Erythrocytic glucose-6-phosphate 864.3875 Automated tissue processor. dehydrogenase assay. Subpart E—Specimen Preparation 864.7375 Glutathione reductase assay. 864.7400 Hemoglobin A2 assay. Reagents 864.7415 Abnormal hemoglobin assay. 864.4010 General purpose reagent. 864.7425 Carboxyhemoglobin assay. 864.4020 Analyte specific reagents. 864.7440 Electrophoretic hemoglobin anal- 864.4400 Enzyme preparations. ysis system. 864.7455 Fetal hemoglobin assay. Subpart F—Automated and Semi- 864.7470 Glycosylated hemoglobin assay. Automated Hematology Devices 864.7490 Sulfhemoglobin assay. 864.7500 Whole blood hemoglobin assays. 864.5200 Automated cell counter. 864.7525 Heparin assay. 864.5220 Automated differential cell 864.7660 Leukocyte alkaline phosphatase counter. test. 864.5240 Automated blood cell diluting appa- 864.7675 Leukocyte peroxidase test. ratus. 864.7695 Platelet factor 4 864.5260 Automated cell-locating device. radioimmunoassay. 864.5300 Red cell indices device. 864.7720 Prothrombin consumption test. 864.5350 Microsedimentation centrifuge. 864.7735 Prothrombin-proconvertin test and 864.5400 Coagulation instrument. thrombotest. 864.5425 Multipurpose system for in vitro 864.7750 Prothrombin time test. coagulation studies. 864.7825 Sickle cell test. 263 VerDate Sep<11>2014 17:19 Sep 28, 2020 Jkt 250077 PO 00000 Frm 00273 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 864.1 21 CFR Ch. I (4–1–20 Edition) 864.7875 Thrombin time test. 864.9875 Transfer set. 864.7900 Thromboplastin generation test. 864.7925 Partial thromboplastin time tests. Subpart K—Products Used In Establish- ments That Manufacture Human Cells, Subpart I—Hematology Reagents Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 864.8100 Bothrops atrox reagent. 864.8150 Calibrator for cell indices. 864.9900 Cord blood processing system and 864.8165 Calibrator for hemoglobin or hem- storage container. atocrit measurement. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 864.8175 Calibrator for platelet counting. 360j, 360l, 371. 864.8185 Calibrator for red cell and white EDITORIAL NOTE: Nomenclature changes to cell counting. part 864 appear at 73 FR 35341, June 23, 2008. 864.8200 Blood cell diluent. 864.8500 Lymphocyte separation medium. 864.8540 Red cell lysing reagent. Subpart A—General Provisions 864.8625 Hematology quality control mix- ture. § 864.1 Scope. 864.8950 Russell viper venom reagent. (a) This part sets forth the classifica- tion of hematology and pathology de- Subpart J—Products Used In Establishments vices intended for human use that are That Manufacture Blood and Blood in commercial distribution. Products (b) The identification of a device in a regulation in this part is not a precise 864.9050 Blood bank supplies. description of every device that is, or 864.9100 Empty container for the collection and processing of blood and blood compo- will be, subject to the regulation. A nents. manufacturer who submits a pre- 864.9125 Vacuum-assisted blood collection market notification submission for a system. device under part 807 may not show 864.9145
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