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 862.1555](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1555) → JNC — Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine

# JNC · Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine

_Clinical Chemistry · 21 CFR 862.1555 · Class 2_

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

## Overview

- **Product Code:** JNC
- **Device Name:** Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine
- **Regulation:** [21 CFR 862.1555](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1555)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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