Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: CZP FDA class 2

Iga, Antigen, Antiserum, Control

Immunology

View full classification →

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.

510(k) Clearances

50+ matches

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

K823566

IMMUNOGLOBULIN CONTROL

Dec 30, 1982

Substantially Equivalent

SYVA CO.

K823567

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM

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.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

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