CIT · Nadh Oxidation/Nad Reduction, Ast/Sgot
Clinical Chemistry · 21 CFR 862.1100 · Class 2
Overview
| Product Code | CIT |
|---|---|
| Device Name | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| Regulation | 21 CFR 862.1100 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 139)
Showing 20 most recent of 139 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- | Seppim S.A.S. | Sep 20, 2010 | SESE |
| K080485 | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | Diasys Diagnostics Systems GmbH | Dec 4, 2008 | SESE |
| K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | Abbott Laboratories | Mar 19, 2008 | SESE |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | Thermofisher Scientific OY | Oct 3, 2007 | SESE |
| K071211 | COBAS C 111 ANALYZER | Roche Diagnostics | Jul 30, 2007 | SESE |
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | Aug 8, 2006 | SESE |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | Wiener Laboratories Saic | Dec 9, 2002 | SESE |
| K013698 | AST (SGOT) | Jas Diagnostics, Inc. | Dec 21, 2001 | SESE |
| K013145 | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. | Wiener Laboratories Saic | Nov 27, 2001 | SESE |
| K010488 | ATAC PAK AST REAGENT KIT | Elan Holdings, Inc. | Apr 9, 2001 | SESE |
| K001679 | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | Ortho-Clinical Diagnostics, Inc. | Jun 28, 2000 | SESE |
| K993468 | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | Dec 16, 1999 | SESE |
| K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | Bayer Corp. | Nov 9, 1999 | SESE |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | Sigma Diagnostics, Inc. | Sep 28, 1999 | SESE |
| K991663 | AST/SGOT | A.P. Total Care, Inc. | Jun 30, 1999 | SESE |
| K990009 | CARESIDE AST | Careside, Inc. | Mar 16, 1999 | SESE |
| K983131 | AST | Abbott Laboratories | Sep 28, 1998 | SESE |
| K981843 | AST | Abbott Laboratories | Jun 29, 1998 | SESE |
| K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | Teco Diagnostics | Jun 29, 1998 | SESE |
| K981225 | ASPARTATE AMINOTRANSFERASE (AST) | Abbott Laboratories | Apr 23, 1998 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Abbott Laboratories — 8 clearances
- Roche Diagnostic Systems, Inc. — 6 clearances
- American Monitor Corp. — 5 clearances
- Coulter Electronics, Inc. — 4 clearances
