Product Code: DAK FDA class 2 21 CFR 866.5240

Complement C1q, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring complement C1q, a recognition subunit of the C1 complex that binds antibody-antigen complexes and initiates the classical complement pathway. The kit includes antigen, antiserum, and control components for use in clinical immunology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAK, regulated under 21 CFR 866.5240, within the Immunology specialty.

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FEI Numbers

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Basic Information

Product Code: DAK
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K031563	BINDAZYME CLQ CIC EIA KIT	Sep 10, 2003	Substantially Equivalent	The Binding Site, Ltd.
K032254	IBL C1Q-CIC CIA TEST	Aug 29, 2003	Substantially Equivalent	Ibl GmbH
K012576	CIC-C1Q EIA	Jan 29, 2002	Substantially Equivalent	American Laboratory Products Co., Ltd.
K973203	THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES	Sep 30, 1998	Substantially Equivalent	Sangstat Medical Corp.
K972873	IMMUSTRIP HAMA IGG	Mar 17, 1998	Substantially Equivalent	Immunomedics, Inc.
K951968	HUMAN C1Q RADIAL IMMUNODIFFUSION KIT	May 30, 1995	Substantially Equivalent	Kent Laboratories, Inc.
K914388	C1 RID KIT	Oct 28, 1991	Substantially Equivalent	The Binding Site, Ltd.
K882829	CIRCULATING IMMUNE COMPLEXES CONTROLS	Aug 04, 1988	Substantially Equivalent	Cytotech, Inc.
K860996	SANASSAY IC TEST	Mar 30, 1987	Substantially Equivalent	Scientific Sales Intl., Inc.
K864312	IC MICROASSAY	Jan 09, 1987	Substantially Equivalent	Diamedix Corp.
K862649	CYTOTECH CIC ENZYME IMMUNOASSAY	Sep 04, 1986	Substantially Equivalent	Cytotech, Inc.
K861499	BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT	Jun 20, 1986	Substantially Equivalent	Biostar Medical Products, Inc.
K853697	BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT	Dec 16, 1985	Substantially Equivalent	Biostar Medical Products, Inc.
K851202	GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL	Apr 29, 1985	Substantially Equivalent	Gilford
K844294	CORDIA IC	Feb 04, 1985	Substantially Equivalent	Cordis Corp.
K833275	GMP CIQ ELISA TEST KIT	Jun 22, 1984	Substantially Equivalent	Gamma Medical Products, Inc.
K833636	ORTHO* SERUM ELISA TEST SYSTEM	Jun 13, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K841541	SERUM COMPLEMENT ACTIVITY TEST-SCAT	Jun 01, 1984	Substantially Equivalent	Collaborative Research, Inc.
K823009	GAMMA CLQ	Nov 05, 1982	Substantially Equivalent	Gamma Medical Products, Inc.
K821949	ORTHO* ALTERNATIVE PATHWAY COMPL. TEST	Aug 27, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K821806	ORTHO CLG IMMUNE COMPLEX TEST SYSTEM	Jun 25, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K792472	ELECTRO-IMMUNO-QUANTITATION (EIQ)	Dec 27, 1979	Substantially Equivalent	Icl Scientific
K781022	ANTI-HUMAN CIQ SERUM	Aug 14, 1978	Substantially Equivalent	Icl Scientific
K780729	LAS-R HUMAN COMPLEMENT CLQ TEST	May 18, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K772114	FIAX C4 ASSAY	Nov 30, 1977	Substantially Equivalent	Idt, A Division of Whittaker M.A. Bioproducts
K772003	HUMAN REFERENCE SERUM C4 COMPLEMENT	Nov 03, 1977	Substantially Equivalent	G.D. Searle and Co.
K770964	GOAT ANTISERUM COMPLEMENT C3 NEPHEL.	Jun 24, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K770547	LAS-R TM HUMAN COMPLEMENT C4 TEST	May 03, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories