Nadh Oxidation/Nad Reduction, Alt/Sgpt
FDA product code CKA · Class I (low risk) · 21 CFR 862.1030 · Clinical Chemistry
127510(k) clearances
0PMA approvals
18recalls
Manufacturers
- Em Diagnostic Systems, Inc. 10
- Boehringer Mannheim Corp. 5
- Harleco 4
- Beckman Instruments, Inc. 4
- Technicon Instruments Corp. 4
- Coulter Electronics, Inc. 4
- American Monitor Corp. 4
- Trace Scientific , Ltd. 4
- Abbott Laboratories 3
- Data Medical Associates, Inc. 3
- Hi Chem, Inc. 3
- Roche Diagnostic Systems, Inc. 3
- Wako Chemicals USA, Inc. 2
- Pointe Scientific, Inc., 2
- Amresco, Inc. 2
- Smithkline Diagnostics, Inc. 2
- Sigma Chemical Co. 2
- Instrumentation Laboratory CO 2
- Diagnostic Chemicals, Ltd. (Usa) 2
- Electro-Nucleonics Laboratories, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K113382 | Ace Alt ReagentCKA · Traditional | Alfa Wassermann | 07/19/2012SE |
| K061020 | Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…CKA · Special | Dade Behring, Inc. | 05/10/2006SE |
| K020487 | Careside AltCKA · Traditional | Careside, Inc. | 06/04/2002SE |
| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | Trace America, Inc. | 02/02/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | Trace America, Inc. | 01/07/1998SE |
| K974003 | Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30CKA · Traditional | Diagnostic Chemicals , Ltd. | 12/05/1997SE |
| K971323 | Alt or SGPTCKA · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
| K965134 | Alt/SgptCKA · Traditional | Derma Media Lab., Inc. | 02/18/1997SE |
| K961123 | Alt Incorporating DSTCKA · Traditional | Trace Scientific , Ltd. | 04/25/1996SE |
| K952427 | CX Alanine, CX Aspartate AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX Creatine…CKA · Traditional | Beckman Instruments, Inc. | 09/21/1995SE |
| K952744 | Alanine Aminotransferase Reagent SystemCKA · Traditional | Medical Diagnostic Technologies, Inc. | 08/07/1995SE |
| K951332 | Paramax Alanine Aminotransferase (GPT) ReagentCKA · Traditional | Dade Intl., Inc. | 06/19/1995SE |
| K951818 | Hichem Alt Reagent KitCKA · Traditional | Hi Chem, Inc. | 05/15/1995SE |
| K944080 | Alt QvetCKA · Traditional | Prisma Systems | 11/22/1994SE |
| K941314 | Stanbio Alt/Gpt (Luqui-Uv) Test SetCKA · Traditional | Stanbio Laboratory | 07/20/1994SE |
| K941497 | Solarcare Alanine Aminotransferase Micro-Plate AssayCKA · Traditional | Solarcare, Inc. | 05/24/1994SE |
| K941287 | Liquid Alt(Sgpt) Reagent SetCKA · Traditional | Pointe Scientific, Inc., | 05/03/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | Em Diagnostic Systems, Inc. | 01/13/1994SE |
| K930070 | Hemocard Hemoglobin ECKA · Traditional | Isolab, Inc. | 04/08/1993SE |
| K925339 | Olylmpus Alanine Aminotransferase ReagentCKA · Traditional | Olympus Corp. | 02/05/1993SE |
| K923510 | Alt (GPT) - Alanine AminotransferaseCKA · Traditional | Randox Laboratories, Ltd. | 11/16/1992SE |
| K924245 | Roche Reagent for AltCKA · Traditional | Roche Diagnostic Systems, Inc. | 10/22/1992SE |
| K923257 | Emds Alanine Aminotransfer Test(Alt) Tech Ra 1000CKA · Traditional | Em Diagnostic Systems, Inc. | 09/28/1992SE |
| K923623 | Il Test Alt, PN 35311CKA · Traditional | Instrumentation Laboratory CO | 09/17/1992SE |
| K922884 | Olympus Alanine Aminotransferase ReagentCKA · Traditional | Olympus Corp. | 07/28/1992SE |
| K922109 | King Diagnostics Alt (GPT) ReagentCKA · Traditional | King Diagnostics, Inc. | 06/04/1992SE |
| K921016 | Synermed Alt/Gpt Reagent KitCKA · Traditional | Synermed, Inc. | 05/07/1992SE |
| K920335 | Miles Alanine Aminotransferase Sera-Pak MethodCKA · Traditional | Heraeus Kulzer, Inc. | 03/24/1992SE |
| K914464 | Abbott Quickstart SGPT, Item Number 5A43CKA · Traditional | Em Diagnostic Systems, Inc. | 11/22/1991SE |
| K913846 | Abbott Quickstart Alanine AminotransferCKA · Traditional | Em Diagnostic Systems, Inc. | 09/19/1991SE |
| K905767 | Coulter Dart Alt (GPT) ReagentCKA · Traditional | Coulter Electronics, Inc. | 01/25/1991SE |
| K903198 | Alanine Aminotransferase TestCKA · Traditional | Em Diagnostic Systems, Inc. | 09/12/1990SE |
| K901702 | Nad Reduction, Alt/Spgt Codes 7722,7723,7422,7522CKA · Traditional | American Research Products Co. | 04/25/1990SE |
| K900905 | Technicon Axon System Reagent MethodsCKA · Traditional | Technicon Instruments Corp. | 04/03/1990SE |
| K901105 | Paramax Alanine Aminotransferase ReagentCKA · Traditional | Baxter Healthcare Corp | 03/23/1990SE |
| K897163 | Coulter Alt (GPT) ReagentCKA · Traditional | Coulter Electronics, Inc. | 03/09/1990SE |
| K896234 | Cobas Ready Stat Profile Reagent StripCKA · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K896001 | Alanine Aminotransferase (Alt)CKA · Traditional | American Monitor Corp. | 11/13/1989SE |
| K892930 | Technicon Dax TM System Additional AnalytesCKA · Traditional | Technicon Instruments Corp. | 07/27/1989SE |
| K893752 | Alanine Aminotransferase Test (Alt) Item # 65403CKA · Traditional | Em Diagnostic Systems, Inc. | 07/20/1989SE |
| K893560 | Alt Reagent (Procedure Number 159)CKA · Traditional | Sigma Chemical Co. | 07/20/1989SE |
| K890698 | Abbott Alt-Activated (Liquid, List #01A55)CKA · Traditional | Abbott Laboratories | 04/10/1989SE |
| K891469 | Alt (GPT) Ifcc 2-VIAL Reagent W/Pyridoxyl PhosphatCKA · Traditional | Trace Scientific , Ltd. | 04/04/1989SE |
| K885144 | Clinistat SGPT (Alt) Serum Glutamate Pyruvate TranCKA · Traditional | Heraeus Kulzer, Inc. | 02/02/1989SE |
| K884376 | Alanine Aminotransferase Test Item No. 65652CKA · Traditional | Em Diagnostic Systems, Inc. | 01/11/1989SE |
| K884936 | Alanine AminotransferaseCKA · Traditional | Catachem, Inc. | 01/03/1989SE |
| K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer ReageCKA · Traditional | Beckman Instruments, Inc. | 09/19/1988SE |
| K883205 | Altlts Alanine Amino Transferase AltCKA · Traditional | Electro-Nucleonics, Inc. | 09/09/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | Miles Laboratories, Inc. | 04/05/1988SE |
| K880275 | Alt (SGPT) Reagent SetCKA · Traditional | Tech-Neal Scientific, Inc. | 03/01/1988SE |
| K874835 | PYRIDOXAL-5-PHOSPHATE TabletsCKA · Traditional | Boehringer Mannheim Corp. | 01/21/1988SE |
| K874586 | Easy-Test Alanine Aminotransferase (Alat) #19017CKA · Traditional | Em Diagnostic Systems, Inc. | 01/21/1988SE |
| K872483 | Modified Alt (GPT) ReagentCKA · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K872830 | Biotrol Alt/Tgp MonoreactifCKA · Traditional | Biotrol, USA, Inc. | 08/13/1987SE |
| K871782 | Ultraviolet Alanine Amino-Trans (Uv-Alt/Uv-Gpt)CKA · Traditional | Biochemical Trade, Inc. | 05/26/1987SE |
| K870879 | Alanine Transaminase (Alt) Test KitCKA · Traditional | Genetic Systems Corp. | 03/19/1987SE |
| K870086 | Alanine Aminotransferase (Alt)/(Gpt)CKA · Traditional | Catachem, Inc. | 03/06/1987SE |
| K864850 | Wako(Tm) Autokit GPTCKA · Traditional | Wako Chemicals USA, Inc. | 01/09/1987SE |
| K864906 | Alanine Amino Transferase Alt/SgptCKA · Traditional | Tech-Co, Inc. | 12/31/1986SE |
| K864335 | Wako GPT II - HaCKA · Traditional | Wako Chemicals USA, Inc. | 12/16/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | J. D. Assoc. | 12/10/1986SE |
| K863962 | Emds(Tm) Alanine Aminotransferase (Alt) #67658/95CKA · Traditional | Em Diagnostic Systems, Inc. | 11/28/1986SE |
| K863253 | Alt/Gpt ProcedureCKA · Traditional | Data Medical Associates, Inc. | 09/16/1986SE |
| K862833 | Model 303-47/303-48 Alanine Aminotransferase KitCKA · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/19/1986SE |
| K861792 | Twin Got-Ast Ifcc/Gpt-Alt IfccCKA · Traditional | Boehringer Mannheim Corp. | 07/29/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | Sterling Diagnostics, Inc. | 06/25/1986SE |
| K861366 | ALT-30, 60 and 100CKA · Traditional | Dimension Diagnostics | 06/25/1986SE |
| K861658 | Alt/Gpt ProcedureCKA · Traditional | Data Medical Associates, Inc. | 05/29/1986SE |
| K861231 | Alt Reagent Cartridge (Product No. 88210)CKA · Traditional | Hi Chem, Inc. | 04/28/1986SE |
| K861002 | Vision SGPT (Alt)CKA · Traditional | Abbott Laboratories | 04/21/1986SE |
| K860727 | Alt(Gpt) (Alanine Aminotransferase) ReagentCKA · Traditional | Trace Scientific , Ltd. | 04/07/1986SE |
| K860110 | Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent SetCKA · Traditional | Technostics Intl. | 02/11/1986SE |
| K854186 | In Vitro Test Determination of Sgpt(Alt)CKA · Traditional | Clinical Data, Inc. | 12/25/1985SE |
| K854502 | Alt(Optimized) ReagentCKA · Traditional | Sigma Diagnostics, Inc. | 11/25/1985SE |
| K852867 | Hi-Chem Diagnostics Enzyme Rinse ConcentrateCKA · Traditional | Hi Chem, Inc. | 08/29/1985SE |
| K851995 | Alt (Alanine Amino-Thransferase)ReagentCKA · Traditional | Alpkem Corp. | 05/30/1985SE |
| K851923 | Amresco Flow Pac Sma Phosphate Buffer ConcentrateCKA · Traditional | Amresco, Inc. | 05/24/1985SE |
| K844251 | Alt/Gpt Reagent SetCKA · Traditional | Sterling Biochemical, Inc. | 01/08/1985SE |
| K843111 | Roche Reagent for AltCKA · Traditional | Roche Diagnostic Systems, Inc. | 10/05/1984SE |
| K843334 | Systemate GPT 67209CKA · Traditional | Em Diagnostic Systems, Inc. | 09/20/1984SE |
| K842564 | Sigma 59-UV for Alanine AminotransferCKA · Traditional | Sigma Chemical Co. | 08/12/1984SE |
| K842241 | Alanine Aminotransferase Assay KitCKA · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/18/1984SE |
| K841060 | SGPT Reagent SetCKA · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K840705 | Paramax Alanine AminotransferaseCKA · Traditional | American Dade | 03/09/1984SE |
| K832639 | Alt -LtsCKA · Traditional | Electro-Nucleonics Laboratories, Inc. | 09/12/1983SE |
| K830959 | Flow-Pac SGPT ReagentCKA · Traditional | Amresco, Inc. | 05/04/1983SE |
| K822494 | Optimized Uv-Gpt Reagent SetCKA · Traditional | Biorent Diagnostic, Inc. | 09/21/1982SE |
| K821206 | Sgpt-Uv Reagent SetCKA · Traditional | Omega Medical Electronics | 07/22/1982SE |
| K821946 | Alt Enzyme Assay KitCKA · Traditional | Travenol Laboratories, S.A. | 07/20/1982SE |
| K821882 | Ultrazyme Plus GPTCKA · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K821805 | PYRIDOXAL-5-PHOSPHATE StripesCKA · Traditional | Boehringer Mannheim Corp. | 07/02/1982SE |
| K821536 | Dowflow Alt-Uv DeterminationCKA · Traditional | The Dow Chemical Co. | 06/14/1982SE |
| K821048 | Liquid-Stat TM Ast-Uv Liquid EnzuneCKA · Traditional | Beckman Instruments, Inc. | 05/03/1982SE |
| K820525 | Raichem GPT (Alt) ReagentCKA · Traditional | Reagents Applications, Inc. | 03/15/1982SE |
| K820394 | Technicon RA-1000 System Add. AnalytCKA · Traditional | Technicon Instruments Corp. | 03/08/1982SE |
| K813495 | Alt (SGPT)CKA · Traditional | Pointe Scientific, Inc., | 12/31/1981SE |
| K812926 | Alt-QuantichromCKA · Traditional | Abbott Laboratories | 11/06/1981SE |
| K812591 | Ultra Zyme Plus GPT, #64956, 65035 & 36CKA · Traditional | Harleco | 09/24/1981SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | Baker Instructions Corp. | 07/01/1981SE |
| K810355 | Alt (UV) TestCKA · Traditional | Boehringer Mannheim Corp. | 02/23/1981SE |
| K801857 | Data-Zyme Lat(Gpt) ProcedureCKA · Traditional | Data Medical Associates, Inc. | 09/16/1980SE |
| K801119 | Cobas Reagent for Alt (GPT)CKA · Traditional | Roche Analytical Instruments, Inc. | 06/09/1980SE |
| K800689 | Reagent for Determ. Glutamic-Pyruvic-CKA · Traditional | Diagnostic Solutions, Inc. | 05/30/1980SE |
| K800115 | Durazyme Gpt/AltCKA · Traditional | American Monitor Corp. | 02/13/1980SE |
| K800038 | Alt ReagentCKA · Traditional | Gilford Diagnostics | 01/21/1980SE |
| K791641 | SGPT Reagent Set ModificationCKA · Traditional | American Monitor Corp. | 09/24/1979SE |
| K791084 | Plus Chem, Determination of Alt (GPT)CKA · Traditional | Smithkline Diagnostics, Inc. | 07/17/1979SE |
| K791083 | Spin Chem, Determination of Alt (GPT)CKA · Traditional | Smithkline Diagnostics, Inc. | 07/17/1979SE |
| K790522 | Coulter Accu-Zyme II GPT ReagentCKA · Traditional | Coulter Electronics, Inc. | 05/01/1979SE |
| K790016 | Serum, Glutamic-PyruvicCKA · Traditional | Fisher Scientific Co., LLC | 02/15/1979SE |
| K781726 | Reagent Set, SGPT Serum GlutamicCKA · Traditional | Medical Analysis Systems, Inc. | 11/03/1978SE |
| K780791 | Sgpt/Alt Reagent SystemCKA · Traditional | American Monitor Corp. | 06/13/1978SE |
| K780636 | Single Vial 10 Sgpt-TrisCKA · Traditional | Boehringer Mannheim Corp. | 05/18/1978SE |
| K780462 | Alt(Gpt) Uni-Uv, SGPTCKA · Traditional | Sclavo, Inc. | 05/12/1978SE |
| K780373 | Stac SystemCKA · Traditional | Technicon Instruments Corp. | 04/28/1978SE |
| K780102 | Ultrazyme Plus GPTCKA · Traditional | Harleco | 02/13/1978SE |
| K780040 | Alanine TransaminaseCKA · Traditional | Beckman Instruments, Inc. | 01/31/1978SE |
| K772030 | Gemsaec Appli. for Ultrazyme Plus GPTCKA · Traditional | Harleco | 11/14/1977SE |
| K771152 | Dynazyme II GPT 340CKA · Traditional | J.T. Baker Chemical Co. | 11/03/1977SE |
| K771466 | Multistat III Alanine AminotransferaseCKA · Traditional | Instrumentation Laboratory CO | 09/02/1977SE |
| K771033 | Smac Sys., Supplemental Products forCKA · Traditional | Mid Tech, Inc. | 08/04/1977SE |
| K770991 | Serum Glutamic Pyruvic TransaminaseCKA · Traditional | Macomb Chemical Co. | 08/02/1977SE |
| K770882 | Ultrazyme Plus GPTCKA · Traditional | Harleco | 07/14/1977SE |
| K770314 | Reagent GPT, EnzymeCKA · Traditional | Icn Pharmaceuticals, Inc. | 03/30/1977SE |
| K761269 | Gemeni GPT (Alt) AssayCKA · Traditional | Electro-Nucleonics Laboratories, Inc. | 12/29/1976SE |
| K760194 | NDC#12739-0010-1 C-Zyme GPTCKA · Traditional | Coulter Electronics, Inc. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2187-2021 Class II | REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE…There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | Abbott Laboratories | 06/10/2021Open, Classified |
| Z-2186-2021 Class II | REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE…There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | Abbott Laboratories | 06/10/2021Open, Classified |
| Z-2185-2021 Class II | REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE…There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | Abbott Laboratories | 06/10/2021Open, Classified |
| Z-2184-2021 Class II | REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c…There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | Abbott Laboratories | 06/10/2021Open, Classified |
| Z-1656-2018 Class II | Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565)…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1650-2018 Class II | Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr:…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1647-2018 Class II | ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-0935-2017 Class III | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | Sterling Diagnostics, Inc. | 07/20/2016Terminated |
| Z-1529-2014 Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For…Extremely low absorbance readings. | Alfa Wassermann, Inc. | 03/05/2014Terminated |
| Z-1066-2011 | Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood…Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of… | Abaxis, Incorporated | 11/19/2010Terminated |
| Z-1117-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1116-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1115-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1114-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1113-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1112-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1111-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |
| Z-1110-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | Pointe Scientific, Inc. | 12/14/2007Terminated |