KQP · Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Clinical Chemistry · 21 CFR 862.1315 · Class 2
Overview
| Product Code | KQP |
|---|---|
| Device Name | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase |
| Regulation | 21 CFR 862.1315 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Jul 15, 2011 | SESE |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | Astoria-Pacific, Inc. | Feb 4, 2011 | SESE |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | Jun 11, 2010 | SESE |
| K993536 | BIO-RAD CODA NEONATAL GALT ASSAY | Bio-Rad | Nov 4, 1999 | SESE |
| K990827 | MICROPLATE NEONATAL GALT ASSAY | Bio-Rad | Apr 9, 1999 | SESE |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Astoria-Pacific, Inc. | Dec 11, 1997 | SESE |
| K894011 | 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
