Product Code: CZP FDA class 2 21 CFR 866.5510

Iga, Antigen, Antiserum, Control

Immunology

The IgA, Antigen, Antiserum, Control test system (product code CZP) is an in-vitro diagnostic device used in immunology to measure immunoglobulin A (IgA) concentrations in serum using antigen-antiserum immunochemical methods, with associated control materials for assay verification, supporting the evaluation of immune deficiency and humoral immunity. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5510 in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code CZP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: CZP
Device Class: FDA class 2
Regulation Number: 866.5510
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 54 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K193525	Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M	Jun 26, 2020	Substantially Equivalent	HORIBA ABX SAS
K060130	IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT	Feb 13, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K040435	ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2	Mar 10, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K024038	N LATEX IGA	Feb 13, 2003	Substantially Equivalent	Dade Behring, Inc.
K993927	WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD	Jan 14, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K983359	IGA	Nov 04, 1998	Substantially Equivalent	Abbott Laboratories
K962200	QUANTEX IGA	Sep 25, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K955794	IGA IMMUNOTURBIDIMETRIC & CALIBRATOR	Apr 05, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K955907	BOEHRINGER MANNHEIM IGA ASSAY	Feb 09, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K952309	N LATEX IGA	Jun 20, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K931806	IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE	Jul 16, 1993	Substantially Equivalent	The Binding Site, Ltd.
K920014	IL TEST IMMUNOGLOBULIN A	Jun 16, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K900422	TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046	Feb 27, 1990	Substantially Equivalent	Helena Laboratories
K894418	RAICHEM(TM) SPIA(TM) IGA REAGENTS	Aug 02, 1989	Substantially Equivalent	Reagents Applications, Inc.
K890560	SPQ(TM) ANTIBODY REAGENT SET II FOR IGA	Feb 15, 1989	Substantially Equivalent	Atlantic Antibodies
K884040	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A	Oct 19, 1988	Substantially Equivalent	Orion Diagnostica, Inc.
K883492	TECHNICON DPA-1 IMMUNOGLOBULIN A	Sep 22, 1988	Substantially Equivalent	Technicon Instruments Corp.
K880803	WAKO(TM) IGA-HA DIRECT	Mar 29, 1988	Substantially Equivalent	Wako Chemicals USA, Inc.
K873869	IMMUNOGLOBULINS A	Oct 13, 1987	Substantially Equivalent	Unipath , Ltd.
K871940	QM300 IGA, ANTIGEN, ANTISERUM, CONTROL	Jun 12, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K863352	PRECIMAT (R) IGA, G, M	Sep 17, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K862763	TINA-QUANT(R) IGA	Sep 04, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K855046	TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT	Aug 27, 1986	Substantially Equivalent	Abbott Laboratories
K862183	DAKO ITA, IMMUNOGLOBULIN A (IGA)	Aug 19, 1986	Substantially Equivalent	Dako Corp.
K861167	IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST	Apr 25, 1986	Substantially Equivalent	Atlantic Antibodies
K855009	QUANTIMETRIC PLUS IGA REAGENT KIT	Feb 26, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K853467	GILFORD IMMUNOGLOBULIN A REAGENT	Sep 16, 1985	Substantially Equivalent	Gilford
K851284	RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM	Jun 11, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K850582	SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A	Mar 01, 1985	Substantially Equivalent	Applications Lab
K843614	CORNING IMMUNOFIXATION SYS	Oct 05, 1984	Substantially Equivalent	Corning Medical & Scientific
K842468	TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG	Aug 28, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K842330	AMER. HISTO-ID SYS PRIMARY IGA 2720-21	Aug 02, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K832263	FITC GOAT ANTI-HUMAN IGA A CHAIN	Oct 31, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K831102	TIA-IGA REAGENT & CALIBRATOR SETS	Apr 27, 1983	Substantially Equivalent	Worthington Diagnostic Systems
K823567	IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM	Dec 30, 1982	Substantially Equivalent	Syva Co.
K823566	IMMUNOGLOBULIN CONTROL	Dec 30, 1982	Substantially Equivalent	Syva Co.
K822026	IMMUNO DIAGNOSTICS ASSAY	Aug 03, 1982	Substantially Equivalent	Helena Laboratories
K812633	ACA IMMUNOGLOBULIN A/M CALIBRATORS	Sep 29, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K812631	ACA IMMUNOGLOBIN A TEST PACK	Sep 29, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K812488	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K812253	GELMAN IG-FIX KIT	Sep 01, 1981	Substantially Equivalent	Gelman Sciences, Inc.
K811125	AIM SYSTEM (FOR IGA)	May 08, 1981	Substantially Equivalent	Icl Scientific
K803274	AUTOMATED IMMUNOPRECIPITIN METHOD/IGA	Jan 26, 1981	Substantially Equivalent	Icl Scientific
K801283	J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY	Jun 30, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K800449	GEMENI IGA ASSAY	Mar 12, 1980	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K800211	IMMUNOGLOBULIN A REAGENT SYSTEM	Feb 19, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K791401	LANCER L-INA ANTI-IGA	Oct 17, 1979	Substantially Equivalent	Sherwood Medical Co.
K790703	ANTISERUM, HUMAN, IGA	Apr 12, 1979	Unknown	Kent Laboratories, Inc.
K790479	A-GENT IMMUNOGLOBULINE TEST SYSTEM	Apr 03, 1979	Substantially Equivalent	Abbott Laboratories
K772076	RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.	Feb 03, 1978	Substantially Equivalent	Gelman Instrument Co.
K772251	IMMUNOGLOBULIN A NEPHEL. ASSAY	Dec 22, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K771603	IMMOCHEMISTRY SYSTEM	Sep 15, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K770962	GOAT ANTISERUM IGA NEPHELOMETRIC	Jun 24, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K760146	SERUM, IGA GOAT ANTI-HUMAN ACID	Jul 20, 1976	Substantially Equivalent	Oxford Laboratories, Inc.