Food and Drug Administration, HHS § 864.7360

§ 864.7280 Leiden DNA muta- § 864.7320 / degrada- tion detection systems. tion products assay. (a) Identification. Factor V Leiden (a) Identification. A fibrinogen/fibrin deoxyribonucleic acid (DNA) degradation products assay is a device detection systems are devices that con- used to detect and measure fibrinogen sist of different reagents and instru- degradation products and fibrin deg- ments which include polymerase chain radation products ( fragments reaction (PCR) primers, hybridization produced by the enzymatic action of matrices, thermal cyclers, imagers, plasmin on fibrinogen and fibrin) as an and software packages. The detection aid in detecting the presence and de- of the Factor V Leiden mutation aids gree of intravascular and in the diagnosis of patients with sus- fibrinolysis (the dissolution of the pected . fibrin in a blood clot) and in moni- (b) Classification. Class II (special toring therapy for disseminated controls). The special control is FDA’s intravascular coagulation (nonlocal- ized clotting in the blood vessels). guidance entitled ‘‘Class II Special Controls Guidance Document: Factor V (b) Classification. Class II (perform- Leiden DNA Mutation Detection Sys- ance standards). tems.’’ (See § 864.1(d) for the avail- [45 FR 60615, Sept. 12, 1980] ability of this guidance document.) § 864.7340 Fibrinogen determination [69 FR 12273, Mar. 16, 2004] system. § 864.7290 Factor deficiency test. (a) Identification. A fibrinogen deter- mination system is a device that con- (a) Identification. A factor deficiency sists of the instruments, reagents, test is a device used to diagnose spe- standards, and controls used to deter- cific coagulation defects, to monitor mine the fibrinogen levels in dissemi- certain types of therapy, to detect co- nated intravascular coagulation (non- agulation inhibitors, and to detect a localized clotting within the blood ves- carrier state (a person carrying both a sels) and primary fibrinolysis (the dis- recessive for a coagulation factor solution of fibrin in a blood clot). deficiency such as hemophilia and the (b) Classification. Class II (perform- corresponding normal gene). ance standards). (b) Classification. Class II (perform- ance standards). [45 FR 60615, Sept. 12, 1980] [45 FR 60613, Sept. 12, 1980] § 864.7360 Erythrocytic glucose-6-phos- phate dehydrogenase assay. § 864.7300 Fibrin monomer (a) Identification. An erythrocytic paracoagulation test. glucose-6-phosphate dehydrogenase (a) Identification. A fibrin monomer assay is a device used to measure the paracoagulation test is a device used to activity of the glucose-6-phos- detect fibrin monomer in the diagnosis phate dehydrogenase or of glucose-6- of disseminated intravascular coagula- phosphate dehydrogenase isoenzymes. tion (nonlocalized clotting within a The results of this assay are used in blood vessel) or in the differential diag- the diagnosis and treatment of nosis between disseminated nonspherocytic congenital hemolytic intravascular coagulation and primary anemia or drug-induced hemolytic ane- fibrinolysis (dissolution of the fibrin in mia associated with a glucose-6-phos- a blood clot). phate dehydrogenase deficiency. This (b) Classification. Class II. The special generic device includes assays based on control for this device is FDA’s ‘‘In fluorescence, electrophoresis, Vitro Diagnostic Fibrin Monomer methemoglobin reduction, catalase in- Paracoagulation Test.’’ hibition, and ultraviolet kinetics. (b) Classification. Class II (perform- [45 FR 60614, Sept. 12, 1980, as amended at 52 ance standards). FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000] [45 FR 60616, Sept. 12, 1980]

273

VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00283 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150