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: DEW FDA class 2

Igg, Antigen, Antiserum, Control

Immunology

View full classification →

This is an immunological reagent kit for detecting and measuring immunoglobulin G (IgG), the predominant immunoglobulin in human serum and the primary mediator of secondary humoral immune responses, using antigen, antiserum, and control components for clinical immunoassay testing. IgG levels are measured to evaluate immune deficiency, autoimmune disorders, and hypergammaglobulinemia. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEW, regulated under 21 CFR 866.5510, within the Immunology specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K050113

TINA-QUANT IGG GEN.2

Feb 08, 2005

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K040434

ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2

Mar 10, 2004

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K010617

SPIFE IFE CALIBRATOR AND CONTROL KIT

Mar 15, 2001

Substantially Equivalent

HELENA LABORATORIES

K993928

WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD

Jan 18, 2000

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K993281

K-ASSAY IGG

Nov 09, 1999

Substantially Equivalent

KAMIYA BIOMEDICAL CO.

K983221

IGG

Nov 04, 1998

Substantially Equivalent

ABBOTT LABORATORIES

K963974

IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN

Mar 06, 1997

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K965108

SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT

Mar 06, 1997

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K963868

IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)

Feb 10, 1997

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K962202

QUANTEX IGG

Sep 26, 1996

Substantially Equivalent

INSTRUMENTATION LABORATORY CO.

K955798

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR

Apr 05, 1996

Substantially Equivalent

RANDOX LABORATORIES, LTD.

K951635

BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL

May 15, 1995

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K943997

BEHRING NEPHELOMETER II

Oct 03, 1994

Substantially Equivalent

BEHRING DIAGNOSTICS, INC.

K934324

OT IGG SORBENT

Apr 21, 1994

Substantially Equivalent

ORGANON TEKNIKA CORP.

K933314

RADIAS FERRITIN ENZYME IMMUNOASSAY

Sep 08, 1993

Substantially Equivalent

BIO-RAD

K924197

ZORBA(TM) IGG REMOVAL REAGENT

Dec 15, 1992

Substantially Equivalent

ZEUS SCIENTIFIC, INC.

K921575

IGG SUCLASS EIA

May 28, 1992

Substantially Equivalent

VIROTECH DIAGNOSTIKA

K911610

ELISA COMBI-KIT HUMAN IGG SUBCLASSES

Jun 12, 1991

Substantially Equivalent

JANSSEN RESEARCH FOUNDATION

K900943

MODIFIED TECHNICON DPA-1(TM) SYSTEM

Apr 26, 1990

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K893419

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

Aug 03, 1989

Substantially Equivalent

COULTER IMMUNOLOGY

K891385

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)

Apr 18, 1989

Substantially Equivalent

VITEK SYSTEMS, INC.

K890416

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG

Feb 22, 1989

Substantially Equivalent

ATLANTIC ANTIBODIES

K882369

ACCRAASSAY RID KITS

Jul 12, 1988

Substantially Equivalent

ICN IMMUNOBIOLOGICALS

K882083

QM300 IGG ANTIBODY PACK

Jul 08, 1988

Substantially Equivalent

KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.

K880784

WAKO(TM) IGG-HA DIRECT

Jun 06, 1988

Substantially Equivalent

WAKO CHEMICALS, USA, INC.

K875254

GULLSORB IGG INACTIVATION REAGENT

Feb 17, 1988

Substantially Equivalent

GULL LABORATORIES, INC.

K875356

IMMUNOGLOBULIN G & G SUBCLASSES

Feb 10, 1988

Substantially Equivalent

BIRMINGHAM

K873870

IMMUNOGLOBULINS G

Oct 13, 1987

Substantially Equivalent

UNIPATH LTD.

K872800

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

Aug 12, 1987

Substantially Equivalent

ABBOTT LABORATORIES

K871340

QM300 IGG ANTIBODY PACK

Apr 22, 1987

Substantially Equivalent

KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.

K871352

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS

Apr 22, 1987

Substantially Equivalent

HELENA LABORATORIES

K862764

TINA-QUANT(R) IGG

Sep 03, 1986

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K861059

DAKO ITA SYSTEM

Aug 25, 1986

Substantially Equivalent

DAKO CORP.

K853465

GILFORD IMMUNOGLOBULIN G REAGENT

Sep 16, 1985

Substantially Equivalent

GILFORD

K852589

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

Jul 15, 1985

Substantially Equivalent

ABBOTT LABORATORIES

K851541

DART IMMUNOGLOBULINS REAGENT SYSTEM

Jul 15, 1985

Substantially Equivalent

COULTER ELECTRONICS, INC.

K850583

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

Mar 01, 1985

Substantially Equivalent

APPLICATIONS LAB

K842329

AMER. HISTO-ID SYS PRIMARY IGG S7920-11

Aug 02, 1984

Substantially Equivalent

BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.

K841816

OPTIMATE IGG TEST

Jun 22, 1984

Substantially Equivalent

MILES LABORATORIES, INC.

K833402

TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN

Jan 24, 1984

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K832258

GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC

Oct 31, 1983

Substantially Equivalent

GELCO DIAGNOSTICS, INC.

K832264

FITC GOAT ANTI-HUMAN IGG Y CHAIN

Oct 28, 1983

Substantially Equivalent

GELCO DIAGNOSTICS, INC.

K831101

TIA-IGG REAGENT & CALIBRATOR SETS

Apr 27, 1983

Substantially Equivalent

WORTHINGTON DIAGNOSTIC SYSTEMS

K830594

TITAN IMMUNO-FIX

Mar 24, 1983

Substantially Equivalent

HELENA LABORATORIES

K821018

ANTIHUMAN IGG GLOBULIN FITC LABELED

Apr 29, 1982

Substantially Equivalent

MICROBIOLOGICAL RESEARCH CORP.

K812484

DAKO PAP KIT K505

Feb 10, 1982

Substantially Equivalent

DAKO CORP.

K812664

ACA IMMUNOGLOBULIN G ANALYTICAL TEST

Oct 02, 1981

Substantially Equivalent

E.I. DUPONT DE NEMOURS & CO., INC.

K812630

ACA IMMUNOGLOBULIN G CALIBRATOR

Sep 29, 1981

Substantially Equivalent

E.I. DUPONT DE NEMOURS & CO., INC.

K812489

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG

Sep 23, 1981

Substantially Equivalent

DAKO CORP.

K812453

SCRIPPSYSTEM IMMUNOGLOBIN RID KIT

Sep 23, 1981

Substantially Equivalent

SCRIPPS-MILES, INC.

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

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump