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 862.1315](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1315) → KQP — Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

# KQP · Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

_Clinical Chemistry · 21 CFR 862.1315 · Class 2_

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

## Overview

- **Product Code:** KQP
- **Device Name:** Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- **Regulation:** [21 CFR 862.1315](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1315)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

## Classification Rationale

Class II.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K102643](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K102643.md) | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Jul 15, 2011 | SESE |
| [K101392](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K101392.md) | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | Astoria-Pacific, Inc. | Feb 4, 2011 | SESE |
| [K100101](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K100101.md) | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | Jun 11, 2010 | SESE |
| [K993536](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K993536.md) | BIO-RAD CODA NEONATAL GALT ASSAY | Bio-Rad | Nov 4, 1999 | SESE |
| [K990827](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K990827.md) | MICROPLATE NEONATAL GALT ASSAY | Bio-Rad | Apr 9, 1999 | SESE |
| [K970277](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K970277.md) | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Astoria-Pacific, Inc. | Dec 11, 1997 | SESE |
| [K894011](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KQP/K894011.md) | TOTAL GALACTOSE | Alpkem Corp. | Jan 11, 1990 | SESE |

## Top Applicants

- Astoria-Pacific, Inc. — 3 clearances
- Bio-Rad — 2 clearances
- Alpkem Corp. — 1 clearance
- Perkinelmer, Inc. — 1 clearance

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

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