Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1460](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1460) → JGG — L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

# JGG · L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

_Clinical Chemistry · 21 CFR 862.1460 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG

## Overview

- **Product Code:** JGG
- **Device Name:** L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
- **Regulation:** [21 CFR 862.1460](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1460)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG/K895850.md) | SYNCHRON CX SYSTEMS (LAP) REAGENT KIT | Beckman Instruments, Inc. | Dec 5, 1989 | SESE |
| [K844965](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG/K844965.md) | LEUCINE AMINOPEPTIDASE REAGENT | Alladin Diagnostic, Inc. | Mar 5, 1985 | SESE |

## Top Applicants

- Alladin Diagnostic, Inc. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG)

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