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 862.1515](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1515) → JMX — Ninhydrin, Nitrogen (Amino-Nitrogen)

# JMX · Ninhydrin, Nitrogen (Amino-Nitrogen)

_Clinical Chemistry · 21 CFR 862.1515 · Class 1_

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

## Overview

- **Product Code:** JMX
- **Device Name:** Ninhydrin, Nitrogen (Amino-Nitrogen)
- **Regulation:** [21 CFR 862.1515](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1515)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.

## 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 the limitations in § 862.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K863188](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX/K863188.md) | HPL RIA KIT | Biotecx Laboratories, Inc. | Sep 25, 1986 | SESE |
| [K780847](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMX/K780847.md) | NINHYDRIN REAGENT KIT | Beckman Instruments, Inc. | Jun 13, 1978 | SESE |

## Top Applicants

- Beckman Instruments, Inc. — 1 clearance
- Biotecx Laboratories, Inc. — 1 clearance

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

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