§ 862.1445 21 CFR Ch. I (4–1–14 Edition)
§ 862.1445 Lactate dehydrogenase premarket notification procedures in isoenzymes test system. subpart E of part 807 of this chapter (a) Identification. A lactate dehydro- subject to § 862.9. genase isoenzymes test system is a de- [52 FR 16122, May 1, 1987, as amended at 65 vice intended to measure the activity FR 2307, Jan. 14, 2000] of lactate dehydrogenase isoenzymes (a group of enzymes with similar biologi- § 862.1465 Lipase test system. cal activity) in serum. Measurements (a) Identification. A lipase test system of lactate dehydrogenase isoenzymes is a device intended to measure the ac- are used in the diagnosis and treat- tivity of the enzymes lipase in serum. ment of liver diseases, such as viral Lipase measurements are used in diag- hepatitis, and myocardial infarction. nosis and treatment of diseases of the (b) Classification. Class II. pancreas such as acute pancreatitis § 862.1450 Lactic acid test system. and obstruction of the pancreatic duct. (b) Classification. Class I (general con- (a) Identification. A lactic acid test trols). The device is exempt from the system is a device intended to measure premarket notification procedures in lactic acid in whole blood and plasma. subpart E of part 807 of this chapter Lactic acid measurements that evalu- subject to § 862.9. ate the acid-base status are used in the diagnosis and treatment of lactic aci- [52 FR 16122, May 1, 1987, as amended at 65 dosis (abnormally high acidity of the FR 2307, Jan. 14, 2000] blood). (b) Classification. Class I (general con- § 862.1470 Lipid (total) test system. trols). The device is exempt from the (a) Identification. A lipid (total) test premarket notification procedures in system is a device intended to measure subpart E of part 807 of this chapter total lipids (fats or fat-like substances) subject to § 862.9. in serum and plasma. Lipid (total) [52 FR 16122, May 1, 1987, as amended at 65 measurements are used in the diag- FR 2307, Jan. 14, 2000] nosis and treatment of various diseases involving lipid metabolism and athero- § 862.1455 Lecithin/sphingomyelin sclerosis. ratio in amniotic fluid test system. (b) Classification. Class I (general con- (a) Identification. A lecithin/ trols). The device is exempt from the sphingomyelin ratio in amniotic fluid premarket notification procedures in test system is a device intended to subpart E of part 807 of this chapter measure the lecithin/sphingomyelin subject to the limitations in § 862.9. ratio in amniotic fluid. Lecithin and [52 FR 16122, May 1, 1987, as amended at 53 sphingomyelin are phospholipids (fats FR 21449, June 8, 1988; 66 FR 38788, July 25, or fat-like substances containing phos- 2001] phorus). Measurements of the lecithin/ sphingomyelin ratio in amniotic fluid § 862.1475 Lipoprotein test system. are used in evaluating fetal maturity. (a) Identification. A lipoprotein test (b) Classification. Class II. system is a device intended to measure § 862.1460 Leucine aminopeptidase lipoprotein in serum and plasma. test system. Lipoprotein measurements are used in the diagnosis and treatment of lipid (a) Identification. A leucine disorders (such as diabetes mellitus), aminopeptidase test system is a device atherosclerosis, and various liver and intended to measure the activity of the renal diseases. enzyme leucine amino-peptidase in serum, plasma, and urine. Leucine (b) Classification. Class I (general con- aminopeptidase measurements are used trols). The device is exempt from the in the diagnosis and treatment of liver premarket notification procedures in diseases such as viral hepatitis and ob- subpart E of part 807 of this chapter structive jaundice. subject to § 862.9. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 trols). The device is exempt from the FR 2307, Jan. 14, 2000]
238
VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00248 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150