FDA Review Panel · IM

FDA 510(k) Immunology Devices

FDA 510(k) Immunology Devices - Regulatory Overview

FDA 510(k) immunology devices include diagnostic systems that detect immune responses, antibodies and antigens. The FDA review panel code is IM.

Key categories:

Immunoassay analyzers - automated platforms for ELISA, CLIA and lateral flow
Allergy testing systems - specific IgE measurement and skin prick test devices
Autoimmune diagnostics - ANA, anti-dsDNA, rheumatoid factor assays
Transplant diagnostics - HLA typing and crossmatch systems

Most devices are Class II under 21 CFR Part 866. Data sourced from FDA 510(k) public files. Updated monthly.

3792

Total

3779

Cleared

232d

Avg (2y)

1976

Since

3125 Immunology devices

676–700 of 3125

Cleared Mar 08, 2004

QUANTA PLEX SLE PROFILE 8

K040160 · Inova Diagnostics, Inc.

LLL · Extractable Antinuclear Antibody, Antigen And Control · 45d

Cleared Mar 05, 2004

IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

K040095 · Immco Diagnostics, Inc.

MVM · Autoantibodies, Endomysial(tissue Transglutaminase) · 45d

Cleared Feb 27, 2004

ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM

K033802 · Zeus Scientific, Inc.

DHR · System, Test, Rheumatoid Factor · 81d

Cleared Feb 03, 2004

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647

K033036 · Beckman Coulter, Inc.

MOI · System, Test, Immunological, Antigen, Tumor · 127d

Cleared Jan 30, 2004

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER

K033811 · The Binding Site, Ltd.

DEH · Lambda, Antigen, Antiserum, Control · 52d

Cleared Jan 08, 2004

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

K034013 · Corgenix, Inc.

LKJ · Antinuclear Antibody, Antigen, Control · 15d

Cleared Dec 29, 2003

GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688

K033038 · Beckman Coulter, Inc.

NIG · System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer · 91d

Cleared Dec 24, 2003

IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

K032571 · Immco Diagnostics, Inc.

MVM · Autoantibodies, Endomysial(tissue Transglutaminase) · 126d

Cleared Oct 14, 2003

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

K032868 · Corgenix, Inc.

MID · System, Test, Anticardiolipin Immunological · 29d

Cleared Sep 29, 2003

BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT

K032240 · The Binding Site, Ltd.

MID · System, Test, Anticardiolipin Immunological · 70d

Cleared Sep 10, 2003

BINDAZYME CLQ CIC EIA KIT

K031563 · The Binding Site, Ltd.

DAK · Complement C1q, Antigen, Antiserum, Control · 114d

Cleared Sep 10, 2003

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

K032535 · Roche Diagnostics Corp.

DHR · System, Test, Rheumatoid Factor · 23d

Cleared Sep 09, 2003

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA

K030701 · Immco Diagnostics, Inc.

MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 187d

Cleared Sep 09, 2003

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

K030702 · Immco Diagnostics, Inc.

MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 187d

Cleared Sep 05, 2003

N/T PROTEIN CONTROL

K032237 · Dade Behring, Inc.

JJY · Multi-analyte Controls, All Kinds (assayed) · 46d

Cleared Aug 07, 2003

K032014 · Dade Behring, Inc.

CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 38d

Cleared Aug 07, 2003

SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI

K032035 · Beckman Coulter, Inc.

CZW · Complement C3, Antigen, Antiserum, Control · 37d

Cleared Jul 23, 2003

LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

K031575 · Cliniqa Corporation

JJY · Multi-analyte Controls, All Kinds (assayed) · 64d

Cleared Jul 17, 2003

FERRITIN GENERATION 2

K031650 · Roche Diagnostics Corp.

DBF · Ferritin, Antigen, Antiserum, Control · 50d

Cleared Jul 15, 2003

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II

K031016 · The Binding Site, Ltd.

DEH · Lambda, Antigen, Antiserum, Control · 106d

Cleared Jul 07, 2003

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

K031208 · Corgenix, Inc.

MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 81d

Cleared Jun 25, 2003

QUANTA PLEX ENA PROFILE 6

K031450 · Inova Diagnostics, Inc.

LLL · Extractable Antinuclear Antibody, Antigen And Control · 49d

Cleared Jun 24, 2003

BAYER ADVIA CENTAUR CA 19-9 ASSAY

K031393 · Bayer Healthcare, LLC

NIG · System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer · 53d

Cleared Jun 19, 2003

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

K031177 · Axis-Shield Diagnostics, Ltd.

MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 66d

Cleared May 15, 2003

TPSA FLEX REAGENT CARTRIDGE

K031343 · Dade Behring, Inc.

LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 16d

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