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) → JNB — Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

# JNB · Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), 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/JNB

## Overview

- **Product Code:** JNB
- **Device Name:** Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), 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 (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K021541](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K021541.md) | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | Perkinelmer Life Sciences | Oct 28, 2002 | SESE |
| [K003584](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K003584.md) | NEOLYNX SCREENING APPLICATION MANAGER | Micromass, Inc. | Mar 19, 2001 | SESE |
| [K000754](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K000754.md) | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | Jun 19, 2000 | SESE |
| [K984463](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K984463.md) | QUANTASE PHE/GAL SCREENING ASSAY | Quantase , Ltd. | Feb 16, 1999 | SESE |
| [K982307](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K982307.md) | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | Wallac, Inc. | Feb 2, 1999 | SESE |
| [K974047](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K974047.md) | ACCUWELL PHENYLALANINE ASSAY | Neometrics, Inc. | Dec 5, 1997 | SESE |
| [K963040](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K963040.md) | MANUAL PHENYLALANINE TEST | Bio-Rad | Oct 1, 1996 | SESE |
| [K960437](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K960437.md) | RADIAS PHENYLALANINE TEST | Bio-Rad | Aug 16, 1996 | SESE |
| [K961515](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K961515.md) | QUANTASE PHENYLALANINE ASSAY | Shield Diagnostics, Ltd. | Jun 12, 1996 | SESE |
| [K943547](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K943547.md) | PHENYLALANINE TEST KIT | Isolab, Inc. | Jan 26, 1996 | SESE |
| [K926106](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K926106.md) | IMMUCHEM PHE-MW EA | Icn Biomedicals, Inc. | Feb 8, 1995 | SESE |
| [K922547](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K922547.md) | QUANTASE PHENYLALANINE ASSAY | Porton Cambridge , Ltd. | Oct 13, 1994 | SESE |
| [K891070](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K891070.md) | PHENYLALANINE (NINHYDRIN REACTION) | Alpkem Corp. | Oct 27, 1989 | SESE |
| [K813449](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K813449.md) | PHE/TYR KINETIC UV TEST SET | P-L Biochemicals, Inc. | Dec 31, 1981 | SESE |
| [K813171](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNB/K813171.md) | PHENYLALANINE UV KINETIC TEST KIT | Biochemicals, Inc. | Dec 3, 1981 | SESE |

## Top Applicants

- Bio-Rad — 2 clearances
- Quantase , Ltd. — 2 clearances
- Alpkem Corp. — 1 clearance
- Biochemicals, Inc. — 1 clearance
- Icn Biomedicals, Inc. — 1 clearance

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

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