Product Code: CDT FDA class 1 21 CFR 862.1705

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Clinical Chemistry

The Lipase Hydrolysis/Glycerol Kinase Enzyme Triglycerides Test is a clinical chemistry device that measures triglyceride concentrations in serum or plasma through a series of enzymatic reactions: lipase hydrolyzes triglycerides to glycerol, which is then phosphorylated by glycerol kinase and further oxidized, producing a measurable signal proportional to triglyceride content, used in lipid profiling and cardiovascular risk assessment. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDT, regulated under 21 CFR 862.1705, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

151

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CDT
Device Class: FDA class 1
Regulation Number: 862.1705
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 151 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K150819	Triglycerides	Aug 06, 2015	Substantially Equivalent	Randox Laboratories Limited
K133067	ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT	Nov 22, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K130332	VITROS CHEMISTRY PRODUCTS TRIG SLIDES	May 31, 2013	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K113830	VANTERA CLINICAL ANALYZER	Aug 30, 2012	Substantially Equivalent	Liposcience
K102993	ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL	May 19, 2011	Substantially Equivalent	Seppim S.A.S.
K063804	OLYMPUS TRIGLYCERIDE TEST SYSTEM	Mar 23, 2007	Substantially Equivalent	Olympus America, Inc.
K043546	DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE	Jan 18, 2005	Substantially Equivalent	Dade Behring, Inc.
K034000	VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR	Mar 10, 2004	Substantially Equivalent	Clinical Data, Inc.
K020488	CARESIDE TRGLYCERIDE	Apr 15, 2002	Substantially Equivalent	Careside, Inc.
K010871	TGL FLEX REAGENT CARTRIDGE	Jul 09, 2001	Substantially Equivalent	Dade Behring, Inc.
K993466	WAKO L-TYPE TRIGLYCERIDE TEST	Nov 09, 1999	Substantially Equivalent	Wako Chemicals USA, Inc.
K971324	TRIGLYCERIDES, TG, OR TRIG	Jun 20, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K971113	DMA TRIGLYCERIDES PROCEDURES	May 29, 1997	Substantially Equivalent	Data Medical Associates, Inc.
K964346	PARAMAX TRIGLYCERID REAGENT	Mar 28, 1997	Substantially Equivalent	Dade Intl., Inc.
K963424	OLYMPUS LIPASE REAGENT	Jan 14, 1997	Substantially Equivalent	Olympus America, Inc.
K961281	TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60	Aug 16, 1996	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K961477	TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY	Aug 05, 1996	Substantially Equivalent	Trace America, Inc.
K933722	HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT	Jun 13, 1996	Substantially Equivalent	Horizon Diagnostics, Inc.
K953971	TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY	Apr 05, 1996	Substantially Equivalent	Trace America, Inc.
K960088	TRUE TRIGLYCERIDE	Apr 01, 1996	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K952741	TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM	Aug 17, 1995	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K942998	TRIGLYCERODES QVET	Nov 22, 1994	Substantially Equivalent	Prisma Systems
K931891	TRIGLYCERIDES	Aug 25, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923508	TRIGLYCERIDES GPO-PAP	Jul 28, 1993	Substantially Equivalent	Randox Laboratories, Ltd.
K924710	TRIGLYCERIDES	Jan 26, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K924573	SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST	Nov 06, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K924694	LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC	Oct 28, 1992	Substantially Equivalent	Olympus Corp.
K922964	KING DIAGNOSTIC TRIGLYCERIDES REAGENT	Aug 18, 1992	Substantially Equivalent	King Diagnostics, Inc.
K922229	OLYMPUS TRIGLYCERIDE REAGENT	Jul 02, 1992	Substantially Equivalent	Olympus Corp.
K915084	BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT	Jan 28, 1992	Substantially Equivalent	Beckman Instruments, Inc.
K915732	ABBOTT QUICKSTART TIGLYCERIDES REAGENT	Jan 15, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K914018	ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33	Nov 22, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K914609	TRIGLYCERIDES REAGENT SET	Nov 07, 1991	Substantially Equivalent	Sterling Diagnostics, Inc.
K910638	SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477	Mar 11, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905601	ECLIPSE ICA TRIGLYCERIDES	Jan 17, 1991	Substantially Equivalent	Biotope, Inc.
K903897	TRIGLYCERIDES REAGENT GPO 5 X CONC.	Oct 01, 1990	Substantially Equivalent	Trace Scientific , Ltd.
K903016	SYNERMED TRIGLYCERIDES REAGENT KIT	Jul 27, 1990	Substantially Equivalent	Synermed, Inc.
K897159	COULTER TRIGLYCERIDES GPO REAGENT	Mar 09, 1990	Substantially Equivalent	Coulter Electronics, Inc.
K897169	QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT	Feb 23, 1990	Substantially Equivalent	Photec Diagnostics, Inc.
K896231	COBAS READY TRIGLYCERIDE REAGENT	Feb 16, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K895952	TRIGLYCERIDES TEST KIT	Jan 11, 1990	Substantially Equivalent	Elite Technology, Inc.
K894310	AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)	Sep 28, 1989	Substantially Equivalent	American Research Products Co.
K893917	EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421	Aug 28, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K893973	ROCHE REAGENT FOR TRIGLYCERIDES	Aug 11, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K890337	TRIGLYCERIDES - GPO REAGENT	Mar 09, 1989	Substantially Equivalent	Alpkem Corp.
K885266	OLYMPUS TRIGLYCERIDES REAGENTS #SR1021	Feb 07, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K883405	TRIGLYCERIDES REAGENT (PRODUCT #88218)	Sep 13, 1988	Substantially Equivalent	Hichem Diagnostics
K881702	BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.	May 27, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K880628	TRIGLYCERIDES (GPO-TRINDER)	Mar 15, 1988	Substantially Equivalent	Tech-Co, Inc.
K880238	TRIGLYCERIDE	Mar 15, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K874584	TRIGLYERIDES TEST KIT	Jan 21, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K874187	A-GENT TRIGLLYCERIDES GPO	Jan 21, 1988	Substantially Equivalent	Abbott Laboratories
K873160	BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR	Sep 08, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K873049	TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL	Aug 28, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K871509	RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)	May 08, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K871508	RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL	May 08, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K871301	ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD	Apr 22, 1987	Substantially Equivalent	American Monitor Corp.
K871122	TRIGLYCERIDES DETERMINATION	Apr 07, 1987	Substantially Equivalent	Biochemical Trade, Inc.
K870827	INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT	Mar 13, 1987	Substantially Equivalent	Intersect Systems, Inc.
K870408	EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608	Mar 04, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K870012	TRIGLYCERIDE (GPO-TRINDER) REAGENT	Feb 20, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K864939	BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT	Dec 31, 1986	Substantially Equivalent	Beckman Instruments, Inc.
K864268	IQ TRIGLYCERIDES	Dec 16, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864231	U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST	Dec 04, 1986	Substantially Equivalent	U. S. Diagnostics, Inc.
K863923	TRIGLYCERIDES	Nov 24, 1986	Substantially Equivalent	Tech-Co, Inc.
K863874	LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES	Nov 13, 1986	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K863254	TRIGLYCERIDE (TRINDER) PROCEDURE	Sep 26, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K863075	TRIGLYCERIDES-E	Sep 26, 1986	Substantially Equivalent	J. D. Assoc.
K862706	EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95	Aug 19, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862033	TRIGLYCERIDES	Jul 22, 1986	Substantially Equivalent	Pointe Scientific, Inc.,
K861670	TRIGLYCERIDE (TRINDER) PROCEDURE	Jul 01, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861793	TWIN TRIGLYCERIDES GPO/CHOLESTEROL	Jun 27, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K861635	TRIGLYCERIDES GPO-TRINDER	Jun 27, 1986	Substantially Equivalent	Catachem, Inc.
K860730	ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)	Apr 07, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K860690	TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS	Mar 17, 1986	Substantially Equivalent	Catachem, Inc.
K855164	ENZYNATIC TRIGLYCERIDES REAGENT SET	Feb 19, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K854783	TRIGLYCERIDE'S TEST (TRIGLI-CINET)	Jan 22, 1986	Substantially Equivalent	Sclavo, Inc.
K854366	ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD	Nov 25, 1985	Substantially Equivalent	American Monitor Corp.
K854182	IN-VITRO TEST DETERMINATION OF TRIALYCERIDE	Nov 25, 1985	Substantially Equivalent	Clinical Data, Inc.
K854152	TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN	Nov 05, 1985	Substantially Equivalent	Technicon Instruments Corp.
K852010	TGL REAGENT	May 30, 1985	Substantially Equivalent	Alpkem Corp.
K851538	TRIGLYCERIDE(TRINDER) PROCEDURE	May 20, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K850667	PERIDOCHROM TRIGLYCERIDES GPO	Mar 11, 1985	Substantially Equivalent	Boehringer Mannheim Corp.
K850031	VISION TRIGLYCERIDES	Feb 04, 1985	Substantially Equivalent	Abbott Laboratories
K843832	TRIGLYCERIDES REAGENT SYSTEM	Nov 27, 1984	Substantially Equivalent	Fermco Biochemics, Inc.
K844032	TRIGLYCERIDE REAGENT	Nov 09, 1984	Substantially Equivalent	Sigma Diagnostics, Inc.
K843536	TRIGLYCERIDE ASSAY KIT GPO-CP	Oct 11, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K843552	TRIGLYCERIDES GPO REAGENT	Sep 26, 1984	Substantially Equivalent	Bio-Rad
K842443	AXIOM STABLE II TRIGLYCERIDES TEST	Sep 13, 1984	Substantially Equivalent	Axiom, Inc.
K843106	SYSTEMATE TRIGLYCERIDE 67219	Aug 27, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842891	QCA TRIGLYCERIDES	Aug 22, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K842029	TRIGLYCERIDES-GPO REAGENT	Jul 09, 1984	Substantially Equivalent	Reagents Applications, Inc.
K842211	ULTRA CHEM ENZYMATIC TRIGLYCERIDE	Jul 06, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K841471	ULTRA CHEM ENZYMATIC TRIGLYCERIDE	May 16, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K841062	TRIGLYCERIDE REAGENT SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K840780	TRIGLYCERIDES REAGENT	Apr 05, 1984	Substantially Equivalent	American Dade
K834518	LIQUID STABLE TRIGLYCERIDES REAGENT SET	Mar 02, 1984	Substantially Equivalent	Medical Analysis Systems, Inc.
K833082	REAGENT SET TRIGLYCERIDES GPO	Nov 25, 1983	Substantially Equivalent	Boehringer Mannheim Corp.
K832871	LIPASE HYDROLYSIS/GLYCEROL KINASE	Oct 14, 1983	Substantially Equivalent	Pointe Scientific, Inc.,
K832684	SERALYZER TRIGLYCERIDES REAGENT STRIPS	Oct 04, 1983	Substantially Equivalent	Miles Laboratories, Inc.
K832426	EASYTOUCH TRIGLYCERIDES REAGENT SET	Sep 12, 1983	Substantially Equivalent	Worthington Diagnostic Systems
K832444	ENZYMATIC TRIGLYCERIDES #2000	Aug 31, 1983	Substantially Equivalent	Stanbio Laboratory
K831858	TRIGLYCERIDES REAGENT SET	Jul 22, 1983	Substantially Equivalent	Stanbio Laboratory
K830288	TRIGLYCERIDE DIAGNOSTIC KIT	Feb 25, 1983	Substantially Equivalent	Sclavo, Inc.
K823709	TRIGLYCERIDE REAGENT (UV)	Jan 07, 1983	Substantially Equivalent	Gilford Diagnostics
K823341	TRIGLYCERIDES REAGENT SET TAG-GK	Dec 22, 1982	Substantially Equivalent	Sterling Biochemical, Inc.
K821205	TRIGLYCERIDE REAGENT SET	Jul 20, 1982	Substantially Equivalent	Omega Medical Electronics
K821875	ULTRACHEM TRI-ES	Jul 13, 1982	Substantially Equivalent	Harleco Diagnostics
K821315	DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM	May 24, 1982	Substantially Equivalent	The Dow Chemical Co.
K812838	TRIGLYCERIDE REAGENT SET	Dec 03, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K812589	ULTRA CHEM E-TRIG #65024	Sep 24, 1981	Substantially Equivalent	Harleco
K812471	SPIN-CHEM TRIGLYCERIDES REAGENT	Sep 14, 1981	Substantially Equivalent	Smithkline Diagnostics, Inc.
K812029	KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)	Aug 03, 1981	Substantially Equivalent	Eastman Kodak Company
K811850	ESKAFLOW TEST FOR TRIGLYCERIDES	Jul 23, 1981	Substantially Equivalent	Smithkline Diagnostics, Inc.
K810965	DATA-ZYME TRIGLYCERIDE	Apr 17, 1981	Substantially Equivalent	Data Medical Associates, Inc.
K810680	ENZYMATIC TRIGLYCERIDE	Mar 31, 1981	Substantially Equivalent	Pointe Scientific, Inc.,
K803297	LUQUIZYME TRIGLYCERIDE REAGENT SET	Jan 16, 1981	Substantially Equivalent	Amresco, Inc.
K803091	TRIGLYCERIDES (UV)-2 REAGENTS	Jan 09, 1981	Substantially Equivalent	Reagents Applications, Inc.
K802256	TRIGLYCERIDES DETERMINATION	Oct 23, 1980	Substantially Equivalent	Coleman Laboratories Corp.
K802136	DELTA TEST TRIGLYCERIDES	Oct 10, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K801891	WAKO TRIGLYCERIDE-G TEST	Sep 16, 1980	Substantially Equivalent	Wako Pure Chemical Industries, Ltd.
K801298	COBAS REAGENT FOR TRIGLYCERIDES & COBAS	Jul 08, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K801226	TRIGLYCERIDES FOR SMA AND AAII	Jun 20, 1980	Substantially Equivalent	Reagents Applications, Inc.
K800649	ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC	May 08, 1980	Substantially Equivalent	Reagents Applications, Inc.
K800301	SIGMA PROCEDURE & REAGENT SYSTEM #335-UV	Mar 05, 1980	Substantially Equivalent	Sigma Chemical Co.
K792480	CHEM-STRATE TRIGLYCERIDE	Dec 27, 1979	Substantially Equivalent	General Diagnostics
K792234	SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES	Nov 27, 1979	Substantially Equivalent	Boehringer Mannheim Corp.
K791640	COULTER ACCU-ZYME II ENZYMATIC REAGENT	Sep 24, 1979	Substantially Equivalent	Coulter Electronics, Inc.
K791597	WAKO TRIGLYCERIDE	Sep 17, 1979	Substantially Equivalent	Wako Pure Chemical Industries, Ltd.
K790773	ENZYMATIC TRIGLYCERIDES-S.V.R.	Jun 15, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K781939	REAGENT KIT, TRIGLYCERIDES	Jan 10, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K781477	TRIGLYCERIDES TEST KIT	Oct 03, 1978	Substantially Equivalent	Mallinckrodt Critical Care
K781466	AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT	Oct 03, 1978	Substantially Equivalent	Fisher Scientific Co., LLC
K781240	ENZYMATIC TRIGLYCERIDES REAGENT KIT	Aug 17, 1978	Substantially Equivalent	J.T. Baker Chemical Co.
K780379	DATA-ZYME TRIGLYCERIDE PROCEDURE	May 12, 1978	Substantially Equivalent	Data Medical Associates, Inc.
K780172	TRIGLYCERIDE INSTRUMENT APPLICATION	Mar 09, 1978	Substantially Equivalent	Harleco
K771906	PHOSPHATE	Dec 06, 1977	Substantially Equivalent	Simmler & Son, Inc.
K771905	GLYCEROL SUBSTRATE	Dec 06, 1977	Substantially Equivalent	Simmler & Son, Inc.
K771904	GLYCEROL KINASE	Dec 06, 1977	Substantially Equivalent	Simmler & Son, Inc.
K771903	LIPASE	Dec 06, 1977	Substantially Equivalent	Simmler & Son, Inc.
K771608	A-GENT TRIGLYCERIDES	Sep 15, 1977	Substantially Equivalent	Abbott Laboratories
K771004	AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI	Sep 12, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K771472	MULTISTAT III TRIGLYCERIDE TEST	Sep 02, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770993	TRIGLYCERIDE REAGENT SET	Sep 02, 1977	Substantially Equivalent	Macomb Chemical Co.
K770841	TRIGLYCERIDE ENZYMATIC METHOD	Jul 14, 1977	Substantially Equivalent	Union Carbide Corp.
K761262	TRIGLYCERIDES (LIPASE) REAGENT SET	Dec 29, 1976	Substantially Equivalent	Worthington Biochemical Corp.
K761200	ENZYMATIC TRIGLYCERIDES (END POINT)	Dec 21, 1976	Substantially Equivalent	Beckman Instruments, Inc.
K760713	TRIGLYCERIDES TEST	Nov 29, 1976	Substantially Equivalent	Boehringer Mannheim Corp.
K760029	ENZYMATIC TRIGLYCERIDE	Sep 15, 1976	Substantially Equivalent	Harleco
K760195	REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1	Aug 03, 1976	Substantially Equivalent	Coulter Electronics, Inc.
K760011	REAGENT, TRIGLYCERIDES	Jul 26, 1976	Substantially Equivalent	The Dow Chemical Co.