Product Code: DBI FDA class 2 21 CFR 866.5240

Complement C4, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring complement C4, a component activated in the classical and lectin pathways of the complement system and reduced in conditions such as systemic lupus erythematosus and hereditary C4 deficiency. The kit includes antigen, antiserum, and control components for in vitro diagnostic testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DBI, regulated under 21 CFR 866.5240, within the Immunology specialty.

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Basic Information

Product Code: DBI
Device Class: FDA class 2
Regulation Number: 866.5240
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 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K100455	SPAPLUS ANALYZER	Sep 03, 2010	Substantially Equivalent	The Binding Site
K012359	TINA-QUANT COMPLEMENT C4 TEST SYSTEM	Nov 29, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K010325	WAKO AUTOKIT C4	Jun 25, 2001	Substantially Equivalent	Wako Chemicals USA, Inc.
K000468	RANDOX COMPLEMENT C4	Mar 27, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K994293	DIMENSION C4 FLEX REAGENT CARTRIDGE	Mar 01, 2000	Substantially Equivalent	Dade Behring, Inc.
K981785	C4 MININEPH ANTISERUM	Dec 20, 1999	Substantially Equivalent	The Binding Site, Ltd.
K993481	K-ASSAY C4	Nov 29, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K983356	C4	Nov 04, 1998	Substantially Equivalent	Abbott Laboratories
K964300	N-ASSAY TIA MULTI V-NL	Jul 14, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K964297	N-ASSAY TIA C4 TEST KIT	Jul 14, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K962582	OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT	Oct 18, 1996	Substantially Equivalent	Olympus America, Inc.
K962198	QUANTEX C4	Sep 26, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K920010	IL TEST COMPLEMENT 4	Mar 13, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K911899	RAICHEM SPIA C4 REAGENT	May 09, 1991	Substantially Equivalent	Reagents Applications, Inc.
K892129	EZ COMPLEMENT C4	Apr 14, 1989	Substantially Equivalent	Diamedix Corp.
K890564	SPQ(TM) ANTIBODY REAGENT SET II FOR C4	Feb 17, 1989	Substantially Equivalent	Atlantic Antibodies
K882621	COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM	Jul 08, 1988	Substantially Equivalent	Technicon Instruments Corp.
K872599	QM300 C4 ANTIBODY PACK	Jul 23, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K871023	PRECIMAT(R) C4	May 14, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K870931	TINA-QUANT(R) (A) C4	Mar 24, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K855012	QUANTIMETRIC PLUS C4 REAGENT KIT	Feb 26, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K853468	GILFORD C4 COMPLEMENT REAGENT	Sep 16, 1985	Substantially Equivalent	Gilford
K850585	SPQ TEST SYSTEM FOR COMPLEMENT C4	Mar 01, 1985	Substantially Equivalent	Applications Lab
K834605	C4 ANTIGEN ANTIBODY CONTROL	Jan 24, 1984	Substantially Equivalent	Technicon Instruments Corp.
K831906	RABBIT ANTISERUM TO HUMAN C4	Jul 19, 1983	Substantially Equivalent	Dako Corp.
K830669	FIAX COMPLEMENT C4 TEST KIT	Apr 08, 1983	Substantially Equivalent	Intl. Diagnostic Technology
K812490	IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K810502	SCRIPPSYSTEM C4 RID KIT	Apr 08, 1981	Substantially Equivalent	Scripps-Miles, Inc.
K802196	GOAT ANTI-HUMAN COMPLEMENT C4	Oct 31, 1980	Substantially Equivalent	Protos Laboratories
K801361	COMPLEMENT C4 NEPHELOMETRIC ASSAY	Jun 30, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K772073	RADIAL IMMUNODIFFUSION KIT-COMP. 3	Feb 03, 1978	Substantially Equivalent	Gelman Instrument Co.
K772247	COMPLEMENT C4 NEPHELOMETRIC ASSAY	Dec 22, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K772004	HUMAN C4 COMPLEMENT CONTROL SERUM	Nov 03, 1977	Substantially Equivalent	G.D. Searle and Co.
K772002	PLATES FOR HUMAN C4 COMPLEMENT	Nov 02, 1977	Substantially Equivalent	G.D. Searle and Co.