JGG · L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
Clinical Chemistry · 21 CFR 862.1460 · Class 1
Overview
| Product Code | JGG |
|---|---|
| Device Name | L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase |
| Regulation | 21 CFR 862.1460 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895850 | SYNCHRON CX SYSTEMS (LAP) REAGENT KIT | Beckman Instruments, Inc. | Dec 5, 1989 | SESE |
| K844965 | LEUCINE AMINOPEPTIDASE REAGENT | Alladin Diagnostic, Inc. | Mar 5, 1985 | SESE |
Top Applicants
- Alladin Diagnostic, Inc. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
