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.
Cleared Devices (139)
| 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 |
| K981221 | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | Abbott Laboratories | Apr 23, 1998 | SESE |
| K980902 | N-ASSAY L AST/GOT | Crestat Diagnostics, Inc. | Mar 26, 1998 | SESE |
| K980666 | INFINITY AST REAGENT (PROCEDURE NO. 51) | Sigma Diagnostics, Inc. | Mar 20, 1998 | SESE |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | Jan 30, 1998 | SESE |
| K974001 | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 | Diagnostic Chemicals , Ltd. | Nov 13, 1997 | SESE |
| K971344 | AST OR SGOT | Carolina Liquid Chemistries Corp. | Apr 21, 1997 | SESE |
| K965126 | AST/SGOT | Derma Media Lab., Inc. | Jan 17, 1997 | SESE |
| K961114 | AST INCORPORATING DST | Trace Scientific , Ltd. | May 23, 1996 | SESE |
| K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | Jan 25, 1996 | SESE |
| K954839 | ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV | Sigma Diagnostics, Inc. | Jan 5, 1996 | SESE |
| K952743 | ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | Sep 29, 1995 | SESE |
| K951751 | HICHEM AST REAGENT KIT | Hichem Diagnostics | Aug 2, 1995 | SESE |
| K944102 | AST QVET | Prisma Systems | Dec 13, 1994 | SESE |
| K941132 | LIQUID AST (SGOT)REAGENT SET | Pointe Scientific, Inc., | May 2, 1994 | SESE |
| K934413 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE | Eastman Kodak Company | Apr 25, 1994 | SESE |
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Em Diagnostic Systems, Inc. | Jan 27, 1994 | SESE |
| K932049 | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 | Stanbio Laboratory | Nov 16, 1993 | SESE |
| K925155 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | Olympus Corp. | Jan 26, 1993 | SESE |
| K924244 | ROCHE REAGENT FOR AST | Roche Diagnostic Systems, Inc. | Jan 4, 1993 | SESE |
| K923505 | AST (GOT) - ASPARTATE AMINOTRANSFERASE | Randox Laboratories, Ltd. | Nov 16, 1992 | SESE |
| K923641 | IL TEST AST, PN 35312 | Instrumentation Laboratory CO | Oct 26, 1992 | SESE |
| K922857 | SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO | Em Diagnostic Systems, Inc. | Sep 9, 1992 | SESE |
| K922885 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | Olympus Corp. | Jul 28, 1992 | SESE |
| K922108 | KING DIAGNOSTICS AST (GOT) REAGENT | King Diagnostics, Inc. | Jul 15, 1992 | SESE |
| K920336 | MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | Mar 4, 1992 | SESE |
| K915555 | SYNERMED AST/GOT REAGENT KIT | Synermed, Inc. | Jan 27, 1992 | SESE |
| K914463 | ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 | Em Diagnostic Systems, Inc. | Jan 3, 1992 | SESE |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | Technicon Instruments Corp. | Nov 22, 1991 | SESE |
| K914068 | ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | Oct 2, 1991 | SESE |
| K905771 | COULTER DART AST (GOT) REAGENT | Coulter Electronics, Inc. | Feb 26, 1991 | SESE |
| K903829 | AST REAGENT | Amresco, Inc. | Sep 25, 1990 | SESE |
| K903197 | ASPARTATE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | Aug 17, 1990 | SESE |
| K901104 | PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT | Baxter Healthcare Corp | Mar 23, 1990 | SESE |
| K897165 | COULTER AST (GOT) REAGENT | Coulter Electronics, Inc. | Feb 23, 1990 | SESE |
| K896233 | COBAS READY LIVER PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K896229 | COBAS READY PROFILE 1 REAGENT STRIP | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K896228 | COBAS READY CARDIO PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | American Monitor Corp. | Jan 11, 1990 | SESE |
| K894180 | ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) | Abbott Laboratories | Sep 13, 1989 | SESE |
| K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 | Diagnostic Systems | Aug 21, 1989 | SESE |
| K892844 | AST REAGENT (PROCEDURE NUMBER 158) | Sigma Chemical Co. | Jun 20, 1989 | SESE |
| K891468 | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | Trace Scientific , Ltd. | May 22, 1989 | SESE |
| K884724 | ASPARTATE AMINOTRANSFERASE (AST) | Catachem, Inc. | Mar 8, 1989 | SESE |
| K885156 | CLINISTAT SGOT (AST) REAGENT TEST | Heraeus Kulzer, Inc. | Feb 2, 1989 | SESE |
| K884377 | ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 | Em Diagnostic Systems, Inc. | Dec 14, 1988 | SESE |
| K880692 | ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) | Diagnostic Chemicals, Ltd. (Usa) | May 27, 1988 | SESE |
| K880276 | AST (SGOT) REAGENT SET | Tech-Neal Scientific, Inc. | Mar 3, 1988 | SESE |
| K875071 | ASPARTATE AMINOTRANSFERASE AST/SGOT | Tech-Co, Inc. | Feb 18, 1988 | SESE |
| K874600 | EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 | Em Diagnostic Systems, Inc. | Jan 21, 1988 | SESE |
| K872829 | BIOTROL AST/TGO MONOREACTIF | Biotrol, USA, Inc. | Aug 13, 1987 | SESE |
| K871780 | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) | Biochemical Trade, Inc. | Jun 4, 1987 | SESE |
| K870077 | ASPARTATE AMINOTRANSFERASE (AST)/(GOT) | Catachem, Inc. | Mar 6, 1987 | SESE |
| K870246 | REFLOTRON(R) AST (GOT) | Boehringer Mannheim Corp. | Feb 18, 1987 | SESE |
| K864813 | WAKO (TM) AUTOKIT GOT TEST | Wako Chemicals USA, Inc. | Feb 13, 1987 | SESE |
| K864357 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | Feb 6, 1987 | SESE |
| K863054 | AST S.C.E. (GOT) | J. D. Assoc. | Jan 13, 1987 | SESE |
| K864302 | WAKO(TM) GOT II - HA | Wako Chemicals USA, Inc. | Dec 16, 1986 | SESE |
| K863963 | EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 | Em Diagnostic Systems, Inc. | Nov 28, 1986 | SESE |
| K863257 | AST/GOT PROCEDURE | Data Medical Associates, Inc. | Sep 26, 1986 | SESE |
| K863094 | SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) | Em Diagnostic Systems, Inc. | Aug 29, 1986 | SESE |
| K862832 | MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT | Diagnostic Chemicals, Ltd. (Usa) | Aug 12, 1986 | SESE |
| K861656 | AST/GOT PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE |
| K860465 | VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM | Abbott Laboratories | May 5, 1986 | SESE |
| K861283 | AST REAGENT CARTRIDGE | Hi Chem, Inc. | Apr 28, 1986 | SESE |
| K860725 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | Apr 7, 1986 | SESE |
| K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET | Sterling Diagnostics, Inc. | Apr 3, 1986 | SESE |
| K854982 | VISION SGOT (AST) | Abbott Laboratories | Jan 14, 1986 | SESE |
| K854503 | AST(OPTIMIZED) REAGENT | Sigma Diagnostics, Inc. | Nov 25, 1985 | SESE |
| K852783 | SGOT/ALT REAGENT | Advanced Biomedical Methods, Inc. | Jul 22, 1985 | SESE |
| K851994 | AST ASPARTATE AMINOTRANSFERASE REAGENT | Alpkem Corp. | Jun 3, 1985 | SESE |
| K851865 | AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE | Amresco, Inc. | May 20, 1985 | SESE |
| K851267 | GEMENI AST-LTS REAGENTS | Electro-Nucleonics Laboratories, Inc. | Apr 29, 1985 | SESE |
| K843109 | ROCHE REAGENT FOR AST | Roche Diagnostic Systems, Inc. | Nov 5, 1984 | SESE |
| K843333 | SYSTEMATE GOT 67208 | Em Diagnostic Systems, Inc. | Sep 20, 1984 | SESE |
| K842521 | AST/GOT REAGENT SET UV RATE | Sterling Biochemical, Inc. | Aug 12, 1984 | SESE |
| K842411 | SIGMA 58-UV ASPARTATE AMINOTRANSFERAS | Sigma Chemical Co. | Aug 12, 1984 | SESE |
| K842245 | ASPARTATE AMINOTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Jul 18, 1984 | SESE |
| K841066 | SGOT-UV REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K840706 | ASPARTATE AMINOTRANSFERASE REAGENT | American Dade | Apr 4, 1984 | SESE |
| K830958 | FLOW-PAC SGOT REAGENT | Amresco, Inc. | May 4, 1983 | SESE |
| K822493 | OPTIMIZED UV-GOT REAGENT SET | Biorent Diagnostic, Inc. | Sep 21, 1982 | SESE |
| K821208 | SGOT-UV REAGENT SET | Omega Medical Electronics | Jul 20, 1982 | SESE |
| K821876 | ULTRAZYME PLUS GOT | Harleco Diagnostics | Jul 13, 1982 | SESE |
| K821433 | BECKMAN LIQUID-STAT AST-UV LIQUID | Beckman Instruments, Inc. | Jun 2, 1982 | SESE |
| K821467 | ULTRAZYME PLUS GOT, #64953,65033&65034 | Emd Chemicals, Inc. | Jun 1, 1982 | SESE |
| K820270 | RAICHEM GOT (AST) REAGENT | Reagents Applications, Inc. | Feb 18, 1982 | SESE |
| K813405 | AST(SGOT) IN VITRO DIAG. REAGENT SET | Pointe Scientific, Inc., | Dec 22, 1981 | SESE |
| K812592 | ULTRA ZYME PLUS GOT #64953, 65033 & 34 | Harleco | Sep 24, 1981 | SESE |
| K802447 | GOT ISOENZYME ASSAY EIKEN KIT | Syn-Kit, Inc. | Apr 17, 1981 | SESE |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | The Dow Chemical Co. | Mar 31, 1981 | SESE |
| K810390 | AST (UV) TEST | Boehringer Mannheim Corp. | Feb 23, 1981 | SESE |
| K803216 | CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT | Union Carbide Corp. | Jan 9, 1981 | SESE |
| K801856 | DATA-ZYME AST(GOT) PROCEDURE | Data Medical Associates, Inc. | Sep 16, 1980 | SESE |
| K801118 | COBAS REAGENT FOR AST (SGOT) | Roche Analytical Instruments, Inc. | Jun 20, 1980 | SESE |
| K800688 | REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC | Diagnostic Solutions, Inc. | May 28, 1980 | SESE |
| K800641 | CENTRIFI CHEM AST/SGOT | Union Carbide Corp. | Apr 10, 1980 | SESE |
| K800116 | DURAZYME GOT/AST | American Monitor Corp. | Feb 13, 1980 | SESE |
| K800065 | ASI REAGENT | Gilford Diagnostics | Feb 5, 1980 | SESE |
| K792208 | DURAZYME GOT/AST | American Monitor Corp. | Nov 27, 1979 | SESE |
| K791679 | NADH OXIDATION, AST/SGOT | American Monitor Corp. | Sep 24, 1979 | SESE |
| K791080 | PLUS CHEM S.C.E. REAGENT | Smithkline Diagnostics, Inc. | Jul 24, 1979 | SESE |
| K791082 | SPIN CHEM REAGENT, DETERMINATION OF AST | Smithkline Diagnostics, Inc. | Jul 17, 1979 | SESE |
| K790483 | COULTER ACCU-ZYME II GOT REAGENT | Coulter Electronics, Inc. | May 3, 1979 | SESE |
| K790017 | SERUM, GLUTAMIC-OXALOACETIC | Fisher Scientific Co., LLC | Feb 26, 1979 | SESE |
| K781784 | AST | Gilford Diagnostics | Jan 3, 1979 | SESE |
| K781725 | REAGENT SET, U.V. ENZMATIC KINETIC, SGOT | Medical Analysis Systems, Inc. | Nov 3, 1978 | SESE |
| K781020 | (AST) OR (ALT) UV DETERM. PHY. PHOS. | The Dow Chemical Co. | Jul 27, 1978 | SESE |
| K780634 | SINGLE VIAL 10 SGOT-TRIS | Boehringer Mannheim Corp. | May 18, 1978 | SESE |
| K780463 | AST(GOT) UNI-UV, SGOT | Sclavo, Inc. | May 12, 1978 | SESE |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | Gamma Enterprises, Inc. | May 3, 1978 | SESE |
| K780443 | SGOT/AST REAGENT SYSTEM | American Monitor Corp. | Apr 24, 1978 | SESE |
| K780103 | ULTRAZYME PLUS GOT | Harleco | Feb 13, 1978 | SESE |
| K780039 | ASPARTATE TRANSAMINASE | Beckman Instruments, Inc. | Jan 31, 1978 | SESE |
| K780013 | SERUM GLUTAMIC OXALOACETIC TRANSAMINASE | Macomb Chemical Co. | Jan 30, 1978 | SESE |
| K772029 | GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT | Harleco | Nov 15, 1977 | SESE |
| K771153 | DYNA ZYME II GOT 340 | J.T. Baker Chemical Co. | Nov 3, 1977 | SESE |
| K770318 | REAGENT GOT, ENZYME | Icn Pharmaceuticals, Inc. | Apr 5, 1977 | SESE |
| K760193 | NDC#12739-0011-1 C-ZYME GOT | Coulter Electronics, Inc. | Aug 3, 1976 | SESE |
| K760010 | COLORIMETRIC DETERMINATION (SGOT/SGPT) | The Dow Chemical Co. | Jul 26, 1976 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Abbott Laboratories — 8 clearances
- Roche Diagnostic Systems, Inc. — 6 clearances
- American Monitor Corp. — 5 clearances
- Trace Scientific , Ltd. — 4 clearances
