CKA · Nadh Oxidation/Nad Reduction, Alt/Sgpt
Clinical Chemistry · 21 CFR 862.1030 · Class 1
Overview
| Product Code | CKA |
|---|---|
| Device Name | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Regulation | 21 CFR 862.1030 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 127)
Showing 20 most recent of 127 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | Hitachi Chemical Diagnostics, Inc. | Jun 7, 2013 | SESE |
| K113382 | ACE ALT REAGENT | Alfa Wassermann | Jul 19, 2012 | SESE |
| K061020 | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE | Dade Behring, Inc. | May 10, 2006 | SESE |
| K020487 | CARESIDE ALT | Careside, Inc. | Jun 4, 2002 | SESE |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | Feb 2, 1998 | SESE |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Trace America, Inc. | Jan 7, 1998 | SESE |
| K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 | Diagnostic Chemicals , Ltd. | Dec 5, 1997 | SESE |
| K971323 | ALT OR SGPT | Carolina Liquid Chemistries Corp. | Apr 21, 1997 | SESE |
| K965134 | ALT/SGPT | Derma Media Lab., Inc. | Feb 18, 1997 | SESE |
| K961123 | ALT INCORPORATING DST | Trace Scientific , Ltd. | Apr 25, 1996 | SESE |
| K952427 | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE | Beckman Instruments, Inc. | Sep 21, 1995 | SESE |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | Aug 7, 1995 | SESE |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | Dade Intl., Inc. | Jun 19, 1995 | SESE |
| K951818 | HICHEM ALT REAGENT KIT | Hi Chem, Inc. | May 15, 1995 | SESE |
| K944080 | ALT QVET | Prisma Systems | Nov 22, 1994 | SESE |
| K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET | Stanbio Laboratory | Jul 20, 1994 | SESE |
| K941497 | SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY | Solarcare, Inc. | May 24, 1994 | SESE |
| K941287 | LIQUID ALT(SGPT) REAGENT SET | Pointe Scientific, Inc., | May 3, 1994 | SESE |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Em Diagnostic Systems, Inc. | Jan 13, 1994 | SESE |
| K930070 | HEMOCARD HEMOGLOBIN E | Isolab, Inc. | Apr 8, 1993 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Boehringer Mannheim Corp. — 5 clearances
- American Monitor Corp. — 4 clearances
- Beckman Instruments, Inc. — 4 clearances
- Coulter Electronics, Inc. — 4 clearances
