21 CFR 862.1460 — L-Leucyl B-Naphthylamide, Leucine Aminopeptidase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1460
Identification
A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino-peptidase in serum, plasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and treatment of liver diseases such as viral hepatitis and obstructive jaundice.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CDC | L-Leucyl B-Naphthylamide, Leucine Aminopeptidase | 1 | 0 | |
| JGG | L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase | 1 | 2 |
