Product Code: CKA FDA class 1 21 CFR 862.1030

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Clinical Chemistry

The NADH Oxidation/NAD Reduction, ALT/SGPT test system (product code CKA) is an in-vitro diagnostic device used in clinical chemistry to measure alanine aminotransferase (ALT/SGPT) activity in serum using a coupled enzymatic UV spectrophotometric method based on NADH oxidation or NAD reduction, the standard kinetic method used in modern clinical analyzers for liver function assessment. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1030 in the Clinical Chemistry medical specialty.

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510(k)s

127

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CKA
Device Class: FDA class 1
Regulation Number: 862.1030
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 127 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K120945	HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST	Jun 07, 2013	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K113382	ACE ALT REAGENT	Jul 19, 2012	Substantially Equivalent	Alfa Wassermann
K061020	DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE	May 10, 2006	Substantially Equivalent	Dade Behring, Inc.
K020487	CARESIDE ALT	Jun 04, 2002	Substantially Equivalent	Careside, Inc.
K980028	ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	Feb 02, 1998	Substantially Equivalent	Trace America, Inc.
K973869	TRACE REAGENT LINE FOR THE COBAS MIRA	Jan 07, 1998	Substantially Equivalent	Trace America, Inc.
K974003	ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30	Dec 05, 1997	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K971323	ALT OR SGPT	Apr 21, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K965134	ALT/SGPT	Feb 18, 1997	Substantially Equivalent	Derma Media Lab., Inc.
K961123	ALT INCORPORATING DST	Apr 25, 1996	Substantially Equivalent	Trace Scientific , Ltd.
K952427	CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE	Sep 21, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K952744	ALANINE AMINOTRANSFERASE REAGENT SYSTEM	Aug 07, 1995	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K951332	PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT	Jun 19, 1995	Substantially Equivalent	Dade Intl., Inc.
K951818	HICHEM ALT REAGENT KIT	May 15, 1995	Substantially Equivalent	Hi Chem, Inc.
K944080	ALT QVET	Nov 22, 1994	Substantially Equivalent	Prisma Systems
K941314	STANBIO ALT/GPT (LUQUI-UV) TEST SET	Jul 20, 1994	Substantially Equivalent	Stanbio Laboratory
K941497	SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY	May 24, 1994	Substantially Equivalent	Solarcare, Inc.
K941287	LIQUID ALT(SGPT) REAGENT SET	May 03, 1994	Substantially Equivalent	Pointe Scientific, Inc.,
K935180	ALANINE AMINOTRANSFERASE (ALT) TEST	Jan 13, 1994	Substantially Equivalent	Em Diagnostic Systems, Inc.
K930070	HEMOCARD HEMOGLOBIN E	Apr 08, 1993	Substantially Equivalent	Isolab, Inc.
K925339	OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT	Feb 05, 1993	Substantially Equivalent	Olympus Corp.
K923510	ALT (GPT) - ALANINE AMINOTRANSFERASE	Nov 16, 1992	Substantially Equivalent	Randox Laboratories, Ltd.
K924245	ROCHE REAGENT FOR ALT	Oct 22, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K923257	EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000	Sep 28, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923623	IL TEST ALT, PN 35311	Sep 17, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K922884	OLYMPUS ALANINE AMINOTRANSFERASE REAGENT	Jul 28, 1992	Substantially Equivalent	Olympus Corp.
K922109	KING DIAGNOSTICS ALT (GPT) REAGENT	Jun 04, 1992	Substantially Equivalent	King Diagnostics, Inc.
K921016	SYNERMED ALT/GPT REAGENT KIT	May 07, 1992	Substantially Equivalent	Synermed, Inc.
K920335	MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD	Mar 24, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K914464	ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43	Nov 22, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K913846	ABBOTT QUICKSTART ALANINE AMINOTRANSFER	Sep 19, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905767	COULTER DART ALT (GPT) REAGENT	Jan 25, 1991	Substantially Equivalent	Coulter Electronics, Inc.
K903198	ALANINE AMINOTRANSFERASE TEST	Sep 12, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K901702	NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522	Apr 25, 1990	Substantially Equivalent	American Research Products Co.
K900905	TECHNICON AXON SYSTEM REAGENT METHODS	Apr 03, 1990	Substantially Equivalent	Technicon Instruments Corp.
K901105	PARAMAX ALANINE AMINOTRANSFERASE REAGENT	Mar 23, 1990	Substantially Equivalent	Baxter Healthcare Corp
K897163	COULTER ALT (GPT) REAGENT	Mar 09, 1990	Substantially Equivalent	Coulter Electronics, Inc.
K896234	COBAS READY STAT PROFILE REAGENT STRIP	Feb 16, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K896001	ALANINE AMINOTRANSFERASE (ALT)	Nov 13, 1989	Substantially Equivalent	American Monitor Corp.
K892930	TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES	Jul 27, 1989	Substantially Equivalent	Technicon Instruments Corp.
K893752	ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403	Jul 20, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K893560	ALT REAGENT (PROCEDURE NUMBER 159)	Jul 20, 1989	Substantially Equivalent	Sigma Chemical Co.
K890698	ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)	Apr 10, 1989	Substantially Equivalent	Abbott Laboratories
K891469	ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT	Apr 04, 1989	Substantially Equivalent	Trace Scientific , Ltd.
K885144	CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN	Feb 02, 1989	Substantially Equivalent	Heraeus Kulzer, Inc.
K884376	ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652	Jan 11, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K884936	ALANINE AMINOTRANSFERASE	Jan 03, 1989	Substantially Equivalent	Catachem, Inc.
K883181	SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE	Sep 19, 1988	Substantially Equivalent	Beckman Instruments, Inc.
K883205	ALTLTS ALANINE AMINO TRANSFERASE ALT	Sep 09, 1988	Substantially Equivalent	Electro-Nucleonics, Inc.
K875079	MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE	Apr 05, 1988	Substantially Equivalent	Miles Laboratories, Inc.
K880275	ALT (SGPT) REAGENT SET	Mar 01, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K874835	PYRIDOXAL-5-PHOSPHATE TABLETS	Jan 21, 1988	Substantially Equivalent	Boehringer Mannheim Corp.
K874586	EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017	Jan 21, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K872483	MODIFIED ALT (GPT) REAGENT	Aug 19, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K872830	BIOTROL ALT/TGP MONOREACTIF	Aug 13, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K871782	ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)	May 26, 1987	Substantially Equivalent	Biochemical Trade, Inc.
K870879	ALANINE TRANSAMINASE (ALT) TEST KIT	Mar 19, 1987	Substantially Equivalent	Genetic Systems Corp.
K870086	ALANINE AMINOTRANSFERASE (ALT)/(GPT)	Mar 06, 1987	Substantially Equivalent	Catachem, Inc.
K864850	WAKO(TM) AUTOKIT GPT	Jan 09, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K864906	ALANINE AMINO TRANSFERASE ALT/SGPT	Dec 31, 1986	Substantially Equivalent	Tech-Co, Inc.
K864335	WAKO GPT II - HA	Dec 16, 1986	Substantially Equivalent	Wako Chemicals USA, Inc.
K863053	ALT S.C.E. (GPT)	Dec 10, 1986	Substantially Equivalent	J. D. Assoc.
K863962	EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95	Nov 28, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863253	ALT/GPT PROCEDURE	Sep 16, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K862833	MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT	Aug 19, 1986	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K861792	TWIN GOT-AST IFCC/GPT-ALT IFCC	Jul 29, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K862209	ALT (SGPT) REAGENT SET (UV RATE)	Jun 25, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K861366	ALT-30, 60 AND 100	Jun 25, 1986	Substantially Equivalent	Dimension Diagnostics
K861658	ALT/GPT PROCEDURE	May 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861231	ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)	Apr 28, 1986	Substantially Equivalent	Hi Chem, Inc.
K861002	VISION SGPT (ALT)	Apr 21, 1986	Substantially Equivalent	Abbott Laboratories
K860727	ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT	Apr 07, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K860110	GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET	Feb 11, 1986	Substantially Equivalent	Technostics Intl.
K854186	IN VITRO TEST DETERMINATION OF SGPT(ALT)	Dec 25, 1985	Substantially Equivalent	Clinical Data, Inc.
K854502	ALT(OPTIMIZED) REAGENT	Nov 25, 1985	Substantially Equivalent	Sigma Diagnostics, Inc.
K852867	HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE	Aug 29, 1985	Substantially Equivalent	Hi Chem, Inc.
K851995	ALT (ALANINE AMINO-THRANSFERASE)REAGENT	May 30, 1985	Substantially Equivalent	Alpkem Corp.
K851923	AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE	May 24, 1985	Substantially Equivalent	Amresco, Inc.
K844251	ALT/GPT REAGENT SET	Jan 08, 1985	Substantially Equivalent	Sterling Biochemical, Inc.
K843111	ROCHE REAGENT FOR ALT	Oct 05, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K843334	SYSTEMATE GPT 67209	Sep 20, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842564	SIGMA 59-UV FOR ALANINE AMINOTRANSFER	Aug 12, 1984	Substantially Equivalent	Sigma Chemical Co.
K842241	ALANINE AMINOTRANSFERASE ASSAY KIT	Jul 18, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841060	SGPT REAGENT SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K840705	PARAMAX ALANINE AMINOTRANSFERASE	Mar 09, 1984	Substantially Equivalent	American Dade
K832639	ALT -LTS	Sep 12, 1983	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K830959	FLOW-PAC SGPT REAGENT	May 04, 1983	Substantially Equivalent	Amresco, Inc.
K822494	OPTIMIZED UV-GPT REAGENT SET	Sep 21, 1982	Substantially Equivalent	Biorent Diagnostic, Inc.
K821206	SGPT-UV REAGENT SET	Jul 22, 1982	Substantially Equivalent	Omega Medical Electronics
K821946	ALT ENZYME ASSAY KIT	Jul 20, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K821882	ULTRAZYME PLUS GPT	Jul 14, 1982	Substantially Equivalent	Harleco Diagnostics
K821805	PYRIDOXAL-5-PHOSPHATE STRIPES	Jul 02, 1982	Substantially Equivalent	Boehringer Mannheim Corp.
K821536	DOWFLOW ALT-UV DETERMINATION	Jun 14, 1982	Substantially Equivalent	The Dow Chemical Co.
K821048	LIQUID-STAT TM AST-UV LIQUID ENZUNE	May 03, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K820525	RAICHEM GPT (ALT) REAGENT	Mar 15, 1982	Substantially Equivalent	Reagents Applications, Inc.
K820394	TECHNICON RA-1000 SYSTEM ADD. ANALYT	Mar 08, 1982	Substantially Equivalent	Technicon Instruments Corp.
K813495	ALT (SGPT)	Dec 31, 1981	Substantially Equivalent	Pointe Scientific, Inc.,
K812926	ALT-QUANTICHROM	Nov 06, 1981	Substantially Equivalent	Abbott Laboratories
K812591	ULTRA ZYME PLUS GPT, #64956, 65035 & 36	Sep 24, 1981	Substantially Equivalent	Harleco
K811694	CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT	Jul 01, 1981	Substantially Equivalent	Baker Instructions Corp.
K810355	ALT (UV) TEST	Feb 23, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K801857	DATA-ZYME LAT(GPT) PROCEDURE	Sep 16, 1980	Substantially Equivalent	Data Medical Associates, Inc.
K801119	COBAS REAGENT FOR ALT (GPT)	Jun 09, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K800689	REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-	May 30, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K800115	DURAZYME GPT/ALT	Feb 13, 1980	Substantially Equivalent	American Monitor Corp.
K800038	ALT REAGENT	Jan 21, 1980	Substantially Equivalent	Gilford Diagnostics
K791641	SGPT REAGENT SET MODIFICATION	Sep 24, 1979	Substantially Equivalent	American Monitor Corp.
K791084	PLUS CHEM, DETERMINATION OF ALT (GPT)	Jul 17, 1979	Substantially Equivalent	Smithkline Diagnostics, Inc.
K791083	SPIN CHEM, DETERMINATION OF ALT (GPT)	Jul 17, 1979	Substantially Equivalent	Smithkline Diagnostics, Inc.
K790522	COULTER ACCU-ZYME II GPT REAGENT	May 01, 1979	Substantially Equivalent	Coulter Electronics, Inc.
K790016	SERUM, GLUTAMIC-PYRUVIC	Feb 15, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K781726	REAGENT SET, SGPT SERUM GLUTAMIC	Nov 03, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K780791	SGPT/ALT REAGENT SYSTEM	Jun 13, 1978	Substantially Equivalent	American Monitor Corp.
K780636	SINGLE VIAL 10 SGPT-TRIS	May 18, 1978	Substantially Equivalent	Boehringer Mannheim Corp.
K780462	ALT(GPT) UNI-UV, SGPT	May 12, 1978	Substantially Equivalent	Sclavo, Inc.
K780373	STAC SYSTEM	Apr 28, 1978	Substantially Equivalent	Technicon Instruments Corp.
K780102	ULTRAZYME PLUS GPT	Feb 13, 1978	Substantially Equivalent	Harleco
K780040	ALANINE TRANSAMINASE	Jan 31, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K772030	GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT	Nov 14, 1977	Substantially Equivalent	Harleco
K771152	DYNAZYME II GPT 340	Nov 03, 1977	Substantially Equivalent	J.T. Baker Chemical Co.
K771466	MULTISTAT III ALANINE AMINOTRANSFERASE	Sep 02, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K771033	SMAC SYS., SUPPLEMENTAL PRODUCTS FOR	Aug 04, 1977	Substantially Equivalent	Mid Tech, Inc.
K770991	SERUM GLUTAMIC PYRUVIC TRANSAMINASE	Aug 02, 1977	Substantially Equivalent	Macomb Chemical Co.
K770882	ULTRAZYME PLUS GPT	Jul 14, 1977	Substantially Equivalent	Harleco
K770314	REAGENT GPT, ENZYME	Mar 30, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K761269	GEMENI GPT (ALT) ASSAY	Dec 29, 1976	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K760194	NDC#12739-0010-1 C-ZYME GPT	Aug 03, 1976	Substantially Equivalent	Coulter Electronics, Inc.