Product Code: DAD FDA class 2 21 CFR 866.5460

Haptoglobin, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and quantifying haptoglobin in patient serum or plasma, providing antigen, antiserum, and control components for clinical laboratory immunoassays. Haptoglobin levels are used to evaluate hemolytic anemia and monitor inflammatory conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DAD, regulated under 21 CFR 866.5460, within the Immunology medical specialty.

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Basic Information

Product Code: DAD
Device Class: FDA class 2
Regulation Number: 866.5460
Medical Specialty: Immunology
Review Panel: IM
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 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K993480	K-ASSAY HAPTOGLOBIN	Nov 24, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K972639	TINA-QUANT HAPTOGLOBIN	Jan 09, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K964301	N-ASSAY TIA MULTI V-NL	Jul 14, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K963286	IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT	Oct 07, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K952593	N/T PROTEIN CONTROL SY/L, M AND H	Jul 17, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K915829	IL TEST(TM) HAPTOGLOBIN (HPT)	Jul 29, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K911898	RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT	May 08, 1991	Substantially Equivalent	Reagents Applications, Inc.
K890562	SPQ(TM) ANTIBODY REAGENT SET II FOR HPT	Feb 22, 1989	Substantially Equivalent	Atlantic Antibodies
K873866	HAPTOGLOBIN	Oct 20, 1987	Substantially Equivalent	Unipath , Ltd.
K872717	QM300 HAPTOGLOBIN ANTIBODY PACK	Jul 21, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K864512	IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO	Feb 13, 1987	Substantially Equivalent	Cooper Biomedical, Inc.
K850584	SPQ TEST SYSTEM FOR HAPTOGLOBIN	Mar 05, 1985	Substantially Equivalent	Applications Lab
K840404	DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO	Mar 09, 1984	Substantially Equivalent	Tago, Inc.
K831957	DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB	Jul 18, 1983	Substantially Equivalent	Kent Laboratories, Inc.
K812494	IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K801433	HAPTOGLOBIN NEPHELOMETRIC ASSAY	Jul 08, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K772245	HAPTOGLOBIN NEPHELOMETRIC ASSAY	Dec 22, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K760144	SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID	Jul 20, 1976	Substantially Equivalent	Oxford Laboratories, Inc.