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 862.1310](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1310) → JIA — Enzymatic Methods, Galactose

# JIA · Enzymatic Methods, Galactose

_Clinical Chemistry · 21 CFR 862.1310 · Class 1_

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

## Overview

- **Product Code:** JIA
- **Device Name:** Enzymatic Methods, Galactose
- **Regulation:** [21 CFR 862.1310](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1310)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

## Classification Rationale

Class I.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190335](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K190335.md) | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | Nov 6, 2019 | SESE |
| [K133652](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K133652.md) | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | Apr 28, 2014 | SESE |
| [K121101](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K121101.md) | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Jun 20, 2013 | SESE |
| [K071649](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K071649.md) | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Wallac OY | Aug 7, 2008 | SESE |
| [K990654](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K990654.md) | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | Jun 21, 1999 | SESE |
| [K990644](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K990644.md) | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | Jun 21, 1999 | SESE |
| [K991498](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K991498.md) | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | Jun 16, 1999 | SESE |
| [K950481](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K950481.md) | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Isolab, Inc. | Feb 1, 1996 | SESE |
| [K951329](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIA/K951329.md) | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | Nov 9, 1995 | SESE |

## Top Applicants

- Quantase , Ltd. — 2 clearances
- Astoria-Pacific, Inc. — 1 clearance
- Icn Pharmaceuticals, Inc. — 1 clearance
- Isolab, Inc. — 1 clearance
- Neometrics, Inc. — 1 clearance

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

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