Product Code: DFC FDA class 2 21 CFR 866.5600

Lipoprotein, Low-Density, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting low-density lipoprotein (LDL), the primary carrier of cholesterol in the bloodstream and a major risk factor for atherosclerosis when elevated, including antigen, antiserum, and control components for clinical laboratory immunoassay testing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DFC, regulated under 21 CFR 866.5600, within the Immunology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DFC
Device Class: FDA class 2
Regulation Number: 866.5600
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

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 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253069	Lipoprotein (a) Molarity Assay	Jun 16, 2026	Substantially Equivalent	Diazyme Laboratories, Inc.
K241220	Tina-quant Lipoprotein(a) Gen.2 Molarity	Jan 24, 2025	Substantially Equivalent	Roche Diagnostics Operations
K211058	Lp(a) Ultra	Dec 22, 2022	Substantially Equivalent	SENTINEL CH. SpA
K180074	Diazyme Lipoprotein (a) Assay	Mar 22, 2018	Substantially Equivalent	Diazyme Laboratories, Inc.
K123046	ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR	Dec 20, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K122722	COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160	Nov 29, 2012	Substantially Equivalent	Roche Diagnostics
K082488	DIAZYME LP(A) ASSAY	Jan 13, 2009	Substantially Equivalent	General Atomics
K063838	LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH	Sep 27, 2007	Substantially Equivalent	Thermo Electron OY
K050487	QUANTIA LA(A)	Apr 26, 2005	Substantially Equivalent	Biokit, S.A.
K023853	K-ASSAY LP(A) CONTROLS	Dec 13, 2002	Substantially Equivalent	Kamiya Biomedical Co.
K021660	K-ASSAY LP(A) ASSAY	Jul 25, 2002	Substantially Equivalent	Kamiya Biomedical Co.
K013359	LP(A)-LATEX SEIKEN ASSAY KIT	Mar 08, 2002	Substantially Equivalent	Denka Seiken'S
K013128	N LATEX LP(A)	Jan 18, 2002	Substantially Equivalent	Dade Behring, Inc.
K013206	TINA-QUANT APOLIPOPROTEIN B VER.2	Nov 16, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K013207	TINA-QUANT APOLIPOPROTEIN B VER.2	Nov 13, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K001934	WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX	Jul 24, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001933	WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO	Jul 24, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001931	WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET	Jul 24, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001929	WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA	Jul 24, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001921	WAKO AUTOKIT LP(A)/EXPRESS 550	Jul 23, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001920	WAKO AUTOKIT LP(A)/ RA,500/1000,	Jul 23, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001919	WAKO AUTOKIT LP(A)/DADE DEMENSION	Jul 23, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K000121	IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB	May 17, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K001118	MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET	Apr 25, 2000	Substantially Equivalent	DiaSorin, Inc.
K994110	LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET	Dec 21, 1999	Substantially Equivalent	Diasorin/American Standard Companies
K992665	MACRA LP(A) ENZYME IMMUNOASSAY KIT	Nov 26, 1999	Substantially Equivalent	Trinity Biotech USA
K993669	LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET	Nov 17, 1999	Substantially Equivalent	DiaSorin, Inc.
K990595	INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B	Apr 14, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K982708	SPQ TEST SYSTEM	Apr 02, 1999	Substantially Equivalent	DiaSorin, Inc.
K981446	WAKO AUTOKIT LP(A)	Mar 09, 1999	Substantially Equivalent	Wako Chemicals USA, Inc.
K983281	APOB	Jan 26, 1999	Substantially Equivalent	Abbott Laboratories
K980812	IMX HOMOCYSTEINE	Oct 01, 1998	Substantially Equivalent	Axis Biochemicals, Asa
K970302	APO-TEK LP(A)	Nov 10, 1997	Substantially Equivalent	Perimmune, Inc.
K954657	WAKO AUTOKIT APO B	Dec 20, 1995	Substantially Equivalent	Wako Chemicals USA, Inc.
K923079	IL TEST CALIBRATION SET APO A1B	Feb 05, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K904137	UC IMU B	Nov 21, 1990	Substantially Equivalent	Eucardio Laboratory, Inc.
K903122	EQUATE(TM) AQR APO AL/B DUO CONTROL	Aug 02, 1990	Substantially Equivalent	Binax, Inc.
K883712	QM300 CONTROL F PACK	Sep 22, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K883711	QM300 CALIBRATOR F PACK	Sep 22, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K872080	RAICHEM(TM) SPIA(TM) APO B REAGENTS	Jun 15, 1987	Substantially Equivalent	Reagents Applications, Inc.
K781015	ANTI-HUMAN LDL SERUM	Aug 14, 1978	Substantially Equivalent	Icl Scientific
K771912	LAS-R BETA LIPOPROTEIN TEST	Oct 19, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K771812	LIPPOPROTEIN ELECTROPHORESIS REAGENT SET	Oct 18, 1977	Substantially Equivalent	Gelman Instrument Co.