Product Code: JJT FDA class 1 21 CFR 862.1660

Enzyme Controls (Assayed And Unassayed)

Clinical Chemistry

This device consists of assayed and unassayed enzyme controls used in clinical chemistry laboratories to verify the accuracy and precision of enzyme activity measurements such as AST, ALT, LDH, and alkaline phosphatase across analytical systems and testing runs. It is classified as FDA Class 1, subject only to general controls with no premarket notification required. The product code is JJT, regulated under 21 CFR 862.1660, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JJT
Device Class: FDA class 1
Regulation Number: 862.1660
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 97 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K090940	SPOTCHECK BLOOD SPOT CONTROL, ASSAYED	Dec 14, 2009	Substantially Equivalent	Astoria-Pacific, Inc.
K062751	MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER	Oct 03, 2006	Substantially Equivalent	Quantimetrix Corp.
K030768	CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL	Mar 21, 2003	Substantially Equivalent	Cliniqa Corporation
K030102	ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3	Jan 24, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K021498	LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL	May 24, 2002	Substantially Equivalent	Bio-Rad
K012656	LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648	Sep 06, 2001	Substantially Equivalent	Bio-Rad
K993723	CARDIASURE CARDIAC MARKERS CONTROL	Nov 23, 1999	Substantially Equivalent	Quantimetrix Corp.
K993715	QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3	Nov 16, 1999	Substantially Equivalent	Seracare Technology
K992430	CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3	Aug 30, 1999	Substantially Equivalent	Medical Analysis Systems, Inc.
K984437	QUANTEX ASO-CRP-RP CONTROL II	Feb 02, 1999	Substantially Equivalent	Instrumentation Laboratory CO
K984277	CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3	Dec 09, 1998	Substantially Equivalent	Medical Analysis Systems, Inc.
K982845	CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3	Aug 21, 1998	Substantially Equivalent	More Diagnostics
K980556	LIQUICHEK CARDIAC MARKERS CONTROL LT	Feb 25, 1998	Substantially Equivalent	Bio-Rad
K974461	TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL	Dec 10, 1997	Substantially Equivalent	Biosite Incorporated
K973974	DADE TRU-LIQUID CARDIAC CONTROL	Nov 06, 1997	Substantially Equivalent	Dade Intl., Inc.
K972976	CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL	Aug 29, 1997	Substantially Equivalent	More Diagnostics
K972408	CARDIAC STATUS CONTROLS	Jul 25, 1997	Substantially Equivalent	Spectral Diagnostics, Inc.
K971777	QUANTEX ASO-CRP-RF CONTROL	May 27, 1997	Substantially Equivalent	Instrumentation Laboratory CO
K970856	CARDIOISOZYME, CK/LD ISOENZYME CONTROL	Apr 08, 1997	Substantially Equivalent	Medical Analysis Systems, Inc.
K965169	STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)	Feb 06, 1997	Substantially Equivalent	Specialized Assays, Inc.
K965168	STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)	Feb 04, 1997	Substantially Equivalent	Specialized Assays, Inc.
K965166	STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)	Feb 04, 1997	Substantially Equivalent	Specialized Assays, Inc.
K961828	LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)	Jun 11, 1996	Substantially Equivalent	Bio-Rad
K960275	OPUS CK-MB & TOTAL CK CONTROLS	Apr 25, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K960246	LIQUID CARDIAC MARKER 1,2,3 ASSAYED	Apr 23, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K950803	ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE	Sep 21, 1995	Substantially Equivalent	Isolab, Inc.
K951293	QUANTITATE ENZYME VERIFIER SET	Apr 20, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K950801	CARDIO REP LD CONTROL - CAT NO. 3325	Mar 30, 1995	Substantially Equivalent	Helena Laboratories
K946146	CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION	Jan 24, 1995	Substantially Equivalent	Clinical Controls, Inc.
K946145	CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL	Jan 24, 1995	Substantially Equivalent	Clinical Controls, Inc.
K944923	CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,	Nov 04, 1994	Substantially Equivalent	Clinical Controls, Inc.
K944247	CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL	Oct 31, 1994	Substantially Equivalent	Cala Diagnostics
K944246	CARDIOCHEX CKMB MASS MEASUREMENT CONTROL	Oct 31, 1994	Substantially Equivalent	Cala Diagnostics
K944243	CARDIOCHEX	Oct 27, 1994	Substantially Equivalent	Cala Diagnostics
K943684	HICHEM ENZYME VERIFIER KIT	Oct 04, 1994	Substantially Equivalent	Hi Chem, Inc.
K932442	CARDIO REP RECOMBINANT CK ABNORMAL CONTROL	Oct 28, 1993	Substantially Equivalent	Helena Laboratories
K930889	ROCHE CARDIOTROL-CK	Jul 06, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K930875	CKMB CONTROL - LEVEL 1,2,3	Apr 13, 1993	Substantially Equivalent	Cala Diagnostics
K930873	CKMB ISOENZYME CONTROL-LEVEL 1,2.3	Apr 13, 1993	Substantially Equivalent	Cala Diagnostics
K925151	LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3	Dec 17, 1992	Substantially Equivalent	Bio-Rad
K905623	CK-MB IMMUNOASSAY CONTROL	Feb 22, 1991	Substantially Equivalent	Seradyn, Inc.
K903430	LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2	Aug 23, 1990	Substantially Equivalent	Bio-Rad
K902321	HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)	Jun 28, 1990	Substantially Equivalent	Hichem Diagnostics
K896465	CLP CK/LD ISOENZYME/IMMUNO CONTROL	Mar 01, 1990	Substantially Equivalent	Creative Laboratory Products, Inc.
K894554	CLP CK/LD ISOENZYME CONTROL	Oct 16, 1989	Substantially Equivalent	Creative Laboratory Products, Inc.
K894207	CK-MB/LD-1 CONTROL SYSTEM	Aug 28, 1989	Substantially Equivalent	Boehringer Mannheim Corp.
K883395	ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY	Sep 19, 1988	Substantially Equivalent	Quantimetrix Medical Industries
K882795	DADE(R) CK-MB IMMUNOASSAY CONTROL	Aug 29, 1988	Substantially Equivalent	Baxter Healthcare Corp
K880701	QUANTIMETRIX SERUM ENZYME CONTROL	Mar 24, 1988	Substantially Equivalent	Quantimetrix Corp.
K880266	MULTI-ENZYME LINEARITY SOLUTION	Feb 18, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K874302	QUANTIMETRIX TOTAL CREATINE KINASE CONTROL	Feb 02, 1988	Substantially Equivalent	Quantimetrix Medical Industries
K874141	TITAN GEL REP CPK/LDH ISOENZYME CONTROL	Nov 04, 1987	Substantially Equivalent	Helena Laboratories
K872646	VIRON(TM)	Sep 14, 1987	Substantially Equivalent	bioMerieux, Inc.
K870738	U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL	Apr 13, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870737	U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL	Apr 13, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K861506	DOCUMENT ENZYME LINEARITY TEST SETS	Jun 13, 1986	Substantially Equivalent	Casco Standards
K861512	EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95	May 23, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861329	ISOTRAK AMYLASE ISOENZYME CONTROL SET	Apr 30, 1986	Substantially Equivalent	Behring Diagnostics, Inc.
K860764	EMDS ENZYME VERIFIER, LEVELS I & II	Apr 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K855006	CANTROL CK/MB CONTROL	Jan 17, 1986	Substantially Equivalent	Canyon Diagnostics, Inc.
K854973	V-TREND OC CPK	Jan 13, 1986	Substantially Equivalent	V-Tech, Inc.
K853373	DELTA TROL I & II	Aug 23, 1985	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K851520	CK/LD ISOENZYMES CONTROLS(HUMAN)	Jun 25, 1985	Substantially Equivalent	Seragen Diagnostics, Inc.
K850907	CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/	Jun 25, 1985	Substantially Equivalent	Cala Diagnostics
K850213	ISOCONTROL SERUM CK-MB	Mar 05, 1985	Substantially Equivalent	Sclavo, Inc.
K850211	ISOCONTROL SERUM LD-	Feb 07, 1985	Substantially Equivalent	Sclavo, Inc.
K843266	ID ZONE NORMAL LD ISOENZYME CONTROL	Sep 13, 1984	Substantially Equivalent	Beckman Instruments, Inc.
K843265	ID ZINE LD ISOENZYME CONTROL ABNORM	Sep 13, 1984	Substantially Equivalent	Beckman Instruments, Inc.
K840793	CK/MB IMMUNO-ISOENZYME CONTROL SERUM	Apr 13, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K822984	ID-ZONE LD ISOENZYME CONTROL	Nov 10, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K822646	QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM	Sep 30, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K821981	TITAN GEL CPK/LDH ISOENZYME CONTROL	Jul 22, 1982	Substantially Equivalent	Helena Laboratories
K821183	TARGET ISOCHECK CONTROL SERUM	May 14, 1982	Substantially Equivalent	Smithkline Diagnostics, Inc.
K820360	AALTO LDH ISOENZYME CONTROL SERUM	Mar 04, 1982	Substantially Equivalent	Aalto Scientific, Ltd.
K812671	EMBRITROL CK-MB CONTROLS	Oct 02, 1981	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K810870	GEMENI CK-MB ISOENZYME ABNORMAL SERUM	Apr 14, 1981	Substantially Equivalent	Gemini, Inc.
K810725	QUALITROL #65057	Mar 31, 1981	Substantially Equivalent	Harleco
K803305	DUPONT 'ACA' CREATINE KINASE VERIFIERS	Jan 16, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K800604	CK ISOENZYME ELECTROPHORESIS CONTROL-I.D	Apr 10, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K791723	QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)	Oct 01, 1979	Substantially Equivalent	Organon, Inc.
K791300	LDH ISOENZYME CONTROL	Aug 16, 1979	Substantially Equivalent	Electrophoresis Corp. of America
K791299	CPK ISOENZYME CONTROL	Aug 16, 1979	Substantially Equivalent	Electrophoresis Corp. of America
K790985	P.A.P. RIA CONTROL SERUM PACK	Jul 17, 1979	Substantially Equivalent	Mallinckrodt Critical Care
K781100	DELTA TEST AMYLASE/LIPASE CONTS. I,II	Aug 14, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780801	ISOZYME - ID CPK MARKER	Jun 13, 1978	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K780554	CLIN. CHEM. CONTROL SERUM-QUANTITATE	Jun 06, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K780204	CHEMISTRY CONTROL & REFERENCE SERUMS	Mar 03, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K780147	ISOENZYME SERUM CONTROL	Feb 23, 1978	Substantially Equivalent	Corning Medical & Scientific
K771800	ACA GLUTAMYL TRANSFERASE	Oct 25, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771740	CARDIOZYME CK-CONTROL LEVEL 1	Oct 19, 1977	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K771439	PATHONORM H & L	Sep 02, 1977	Substantially Equivalent	Nyegaard & Co. A/S
K771438	AUTONORM	Sep 02, 1977	Substantially Equivalent	Nyegaard & Co. A/S
K771436	SERONORM	Sep 02, 1977	Substantially Equivalent	Nyegaard & Co. A/S
K770973	CARDIOZYME CK CONTROL NORMAL	Aug 04, 1977	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K770971	CARDIOZYME CK-CONTROL ABNORMAL	Aug 04, 1977	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K770555	CPK ISOENZYME CONTROL	Jun 03, 1977	Substantially Equivalent	Bio-Reagents & Diagnostics, Inc.
K770049	LDH ISOTROL T	Jan 26, 1977	Substantially Equivalent	Sigma Chemical Co.