21 CFR Ch. I (4–1–10 Edition) § 862.1440

§ 862.1440 21 CFR Ch. I (4–1–10 Edition)

intended to identify ketones in urine Lactic acid measurements that evalu- and other body fluids. Identification of ate the acid-base status are used in the ketones is used in the diagnosis and diagnosis and treatment of lactic aci- treatment of acidosis (a condition dosis (abnormally high acidity of the characterized by abnormally high acid- blood). ity of body fluids) or ketosis (a condi- (b) Classification. Class I (general con- tion characterized by increased produc- trols). The device is exempt from the tion of ketone bodies such as acetone) premarket notification procedures in and for monitoring patients on subpart E of part 807 of this chapter ketogenic diets and patients with dia- subject to § 862.9. betes. (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] premarket notification procedures in § 862.1455 Lecithin/sphingomyelin subpart E of part 807 of this chapter ratio in amniotic fluid test system. subject to § 862.9. (a) Identification. A lecithin/ [52 FR 16122, May 1, 1987, as amended at 65 sphingomyelin ratio in amniotic fluid FR 2307, Jan. 14, 2000] test system is a device intended to § 862.1440 Lactate dehydrogenase test measure the lecithin/sphingomyelin system. ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats (a) Identification. A lactate dehydro- or fat-like substances containing phos- genase test system is a device intended phorus). Measurements of the lecithin/ to measure the activity of the enzyme sphingomyelin ratio in amniotic fluid lactate dehydrogenase in serum. Lac- are used in evaluating fetal maturity. tate dehydrogenase measurements are (b) Classification. Class II. used in the diagnosis and treatment of liver diseases such as acute viral hepa- § 862.1460 Leucine aminopeptidase titis, cirrhosis, and metastatic car- test system. cinoma of the liver, cardiac diseases such as myocardial infarction, and tu- (a) Identification. A leucine mors of the lung or kidneys. aminopeptidase test system is a device (b) Classification. Class II (special intended to measure the activity of the controls). The device is exempt from enzyme leucine amino-peptidase in the premarket notification procedures serum, plasma, and urine. Leucine in subpart E of part 807 of this chapter aminopeptidase measurements are used subject to § 862.9. in the diagnosis and treatment of liver diseases such as viral hepatitis and ob- [52 FR 16122, May 1, 1987, as amended at 63 structive jaundice. FR 59225, Nov. 3, 1998] (b) Classification. Class I (general controls). The device is exempt from the § 862.1445 Lactate dehydrogenase isoenzymes test system. premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A lactate dehydro- subject to § 862.9. genase isoenzymes test system is a device intended to measure the activity [52 FR 16122, May 1, 1987, as amended at 65 of lactate dehydrogenase isoenzymes (a FR 2307, Jan. 14, 2000] group of enzymes with similar biologi- cal activity) in serum. Measurements § 862.1465 Lipase test system. of lactate dehydrogenase isoenzymes (a) Identification. A lipase test system are used in the diagnosis and treat- is a device intended to measure the ac- ment of liver diseases, such as viral tivity of the enzymes lipase in serum. hepatitis, and myocardial infarction. Lipase measurements are used in diag- (b) Classification. Class II. nosis and treatment of diseases of the pancreas such as acute pancreatitis § 862.1450 Lactic acid test system. and obstruction of the pancreatic duct. (a) Identification. A lactic acid test (b) Classification. Class I (general con- system is a device intended to measure trols). The device is exempt from the lactic acid in whole blood and plasma. premarket notification procedures in

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