Product Code: LBS FDA class 1 21 CFR 862.1475

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Clinical Chemistry

This test method uses LDL and VLDL precipitation followed by cholesterol measurement via the esterase-oxidase enzymatic method to quantify HDL cholesterol in serum samples for cardiovascular risk assessment. It is classified as FDA Class 1, subject only to general controls, with no premarket notification required. The product code is LBS, regulated under 21 CFR 862.1475, in the Clinical Chemistry specialty. No special risk flags apply.

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Basic Information

Product Code: LBS
Device Class: FDA class 1
Regulation Number: 862.1475
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 80 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162593	HDL-Cholesterol Gen.4	Oct 19, 2016	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K153435	Direct HDL Cholesterol (HDL)	Jan 08, 2016	Substantially Equivalent	Randox Laboratories, Ltd.
K132711	CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT	May 08, 2014	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K120609	VITROS CHEMISTRY PRODUCTS DHDL SLIDES	Sep 07, 2012	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K111516	NMR LIPOPROFILE (R) TEST AND NMR PROFILER	Sep 27, 2011	Substantially Equivalent	Liposcience, Inc.
K103747	ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS	Aug 31, 2011	Substantially Equivalent	Elitechgroup Seppim S.A.S.
K111036	EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT	Jul 12, 2011	Substantially Equivalent	Medica Corporation
K100550	POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC	Sep 28, 2010	Substantially Equivalent	Polymedco, Inc.
K100010	HDL CHOLESTEROL (HDLX) ASSAY	May 14, 2010	Substantially Equivalent	Beckman Coulter, Inc.
K080125	APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201	Jul 18, 2008	Substantially Equivalent	Wako Chemicals USA, Inc.
K073497	HDL CHOLESTEROL REAGENT, MODEL 10211	Apr 14, 2008	Substantially Equivalent	Medica Corp.
K072395	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	Jan 03, 2008	Substantially Equivalent	Diazyme Laboratories
K072836	CHOLESTRAK HDL CHOLESTEROL HOME TEST	Dec 27, 2007	Substantially Equivalent	Accutech, LLC
K071706	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)	Dec 20, 2007	Substantially Equivalent	Clinical Data, Inc.
K062092	PREVU POINT OF CARE SKIN STEROL TEST	Sep 15, 2006	Unknown	Premd, Inc.
K053157	AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A	Dec 09, 2005	Substantially Equivalent	Dade Behring, Inc.
K051962	ULTRA HDL	Aug 25, 2005	Substantially Equivalent	Abbott Laboratories
K050632	ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY	May 26, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K041928	HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B	Nov 23, 2004	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K041090	HDL-EX SEIKEN ASSAY KIT	Oct 29, 2004	Substantially Equivalent	Denka Seiken Co., Ltd.
K042006	VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE	Oct 28, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K042195	SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747	Sep 16, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K040767	SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT	Jun 07, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K032932	DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR	Mar 10, 2004	Substantially Equivalent	Stanbio Laboratory
K033610	HDL-CHOLESTEROL PLUS 2ND GENERATION	Dec 05, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K023640	PICCOLO HDL TEST SYSTEM	Jan 24, 2003	Substantially Equivalent	Abaxis, Inc.
K021316	ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR	Jul 25, 2002	Substantially Equivalent	Genzyme Corp.
K021671	JAS HDL CHOLESTEROL (AUTOMATED) REAGENT	Jul 19, 2002	Substantially Equivalent	Jas Diagnostics, Inc.
K014018	CHOLESTEROL 1, 2, 3	Jun 24, 2002	Unknown	Imi
K014032	OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA	Feb 08, 2002	Substantially Equivalent	Olympus America, Inc.
K014015	OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA	Feb 08, 2002	Substantially Equivalent	Olympus America, Inc.
K013152	ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS	Nov 09, 2001	Substantially Equivalent	Elan Holdings, Inc.
K012286	MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION	Aug 08, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K991664	LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01	Aug 19, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K991665	HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01	Aug 10, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K990581	DIRECT HDL-CHOLESTEROL REAGENT	Jun 18, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K982539	HDLC PRECIPITATING REAGENT	Sep 15, 1998	Substantially Equivalent	Ac Biochemicals, Inc.
K981224	DIRECT HDL	Aug 03, 1998	Substantially Equivalent	Abbott Laboratories
K982341	DIRECT HDL-CHOLESTROL LIQUID	Jul 30, 1998	Substantially Equivalent	Randox Laboratories, Ltd.
K981899	CARESIDE HDL-CHOLESTEROL	Jul 14, 1998	Substantially Equivalent	Exigent Diagnostics, Inc.
K981580	HDL	Jun 11, 1998	Substantially Equivalent	Abbott Laboratories
K973988	RDI HOMOGENEOUS HDL CHOLESTEROL TEST	Dec 22, 1997	Substantially Equivalent	Reference Diagnostics, Inc.
K972041	EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)	Jul 22, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K971902	ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT	Jun 16, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K971190	N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR	Jun 16, 1997	Substantially Equivalent	Genzyme Corp.
K971162	LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR	Jun 16, 1997	Substantially Equivalent	Genzyme Corp.
K970735	BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL	Jun 06, 1997	Substantially Equivalent	Randox Laboratories, Ltd.
K971526	ACE HDL-C REAGENT	May 21, 1997	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K963213	BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL	Oct 23, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K954778	CHOLESTECH LDX SYSTEM	Nov 24, 1995	Substantially Equivalent	Cholestech Corp.
K943279	ACCUMETER HDL CHOLESTEROL TEST	May 01, 1995	Substantially Equivalent	Chemtrak, Inc.
K943028	HDL QVET	Dec 07, 1994	Substantially Equivalent	Prisma Systems
K934045	BECKMAN HDL CHOLESTEROL REAGENT	Oct 14, 1993	Substantially Equivalent	Beckman Instruments, Inc.
K914511	TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL	Nov 27, 1991	Substantially Equivalent	Technicon Instruments Corp.
K905296	CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL	Dec 26, 1990	Substantially Equivalent	Cholestech Corp.
K900036	IMMUNOTECH HDL-CHOLESTEROL TEST	Mar 09, 1990	Substantially Equivalent	Immunotech Corp.
K895139	CLINISTAT HDL CHOLESTEROL REAGENT TEST	Dec 27, 1989	Substantially Equivalent	Heraeus Kulzer, Inc.
K895851	SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT	Nov 29, 1989	Substantially Equivalent	Beckman Instruments, Inc.
K894057	QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT	Aug 31, 1989	Substantially Equivalent	Photec Diagnostics, Inc.
K893548	SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP	Aug 03, 1989	Substantially Equivalent	Heraeus Kulzer, Inc.
K881891	IQ HDL CHOLESTEROL	Jun 10, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K874397	EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683	Nov 24, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K871265	ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL	Aug 13, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K872050	PARAMAX CHOLESTEROL REAGENT	Jul 07, 1987	Substantially Equivalent	American Dade
K871461	VISION (TM) HDL CHOLESTEROL	May 14, 1987	Substantially Equivalent	Abbott Laboratories
K864522	ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE	Feb 04, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K861244	HDL/CHOLESTEROL TEST SYSTEM	Sep 29, 1986	Substantially Equivalent	Chrometrics Laboratories, Inc.
K862845	EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95	Aug 29, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K843029	HIGH DENSITY LIPOPROTEIN PRECIPITATIN	Aug 27, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K840677	HDL EZ-TZ3 CHOLESTEROL REAGENT KIT	Apr 13, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K840676	PDC HDL EZ-SEP CHOLESTEROL REAGENT	Apr 04, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K813192	HDL-C EIKEN	Nov 27, 1981	Substantially Equivalent	Syn-Kit, Inc.
K801834	WAKO HDL CHOLESTEROL TEST	Sep 16, 1980	Substantially Equivalent	Wako Pure Chemical Industries, Ltd.
K801726	HDL CHOLESTEROL TEST KIT	Sep 09, 1980	Substantially Equivalent	Mallinckrodt Critical Care
K801133	CENTRIFICHEM HDL CHOLESTEROL	Jun 17, 1980	Substantially Equivalent	Union Carbide Corp.
K792319	COULTER HDL CHOLESTEROL REAG. SYSTEM	Dec 06, 1979	Substantially Equivalent	Coulter Electronics, Inc.
K792183	DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO	Nov 13, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K791990	TECHNICON HDL CHOLESTEROL METHOD	Oct 17, 1979	Substantially Equivalent	Technicon Instruments Corp.
K790553	CHOLESTEROL KIT, HDL-DS	Jun 15, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K790281	DIAGNOSTIC SET, LIPO-FRAX	Mar 21, 1979	Substantially Equivalent	Analytical Products, Inc.