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
751–775 of 3125
Cleared Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · Beckman Coulter, Inc.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 44d
Cleared Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · Tosoh Medics, Inc.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 14d
Cleared Nov 27, 2002
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · Bayer Diagnostics Corp.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 132d
Cleared Nov 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · Bayer Diagnostics Corp.
MOI · System, Test, Immunological, Antigen, Tumor · 132d
Cleared Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · Axis-Shield Diagnostics, Ltd.
NHX · Antibodies, Anti-cyclic Citrullinated Peptide (ccp) · 23d
Cleared Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · Bayer Diagnostics Corp.
LOJ · Kit, Test,alpha-fetoprotein For Testicular Cancer · 203d
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · Corgenix, Inc.
MID · System, Test, Anticardiolipin Immunological · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · Corgenix, Inc.
MID · System, Test, Anticardiolipin Immunological · 16d
Cleared Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
K021648 · Inova Diagnostics, Inc.
NJF · Antibodies, Anti-actin, Anti-smooth Muscle · 123d
Cleared Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
K022991 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 8d
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · Boston Scientific
DBY · Fab, Rhodamine, Antigen, Antiserum, Control · 78d
Cleared Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · Wako Chemicals USA, Inc.
DHR · System, Test, Rheumatoid Factor · 167d
Cleared Aug 15, 2002
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · The Binding Site, Ltd.
JZG · System, Test, Beta-2-microglobulin Immunological · 231d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
K022525 · Bio-Rad
JJS · Controls For Blood-gases, (assayed And Unassayed) · 15d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · Kamiya Biomedical Co.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 16d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · Roche Diagnostics Corp.
JZO · System, Test, Thyroid Autoantibody · 157d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482 · Inova Diagnostics, Inc.
NIY · Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis · 83d
Cleared Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · Bayer Corp.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 132d
Cleared Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · Axis-Shield Diagnostics, Ltd.
NHX · Antibodies, Anti-cyclic Citrullinated Peptide (ccp) · 74d
Cleared Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc.
DCN · System, Test, C-reactive Protein · 66d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · Bio-Rad Laboratories, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 22d
Cleared Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · The Binding Site, Ltd.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 20d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · Diamedix Corp.
DHR · System, Test, Rheumatoid Factor · 68d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607 · Reference Diagnostics, Inc.
JIT · Calibrator, Secondary · 42d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 87d

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All categories 3125 DHB System, Test, Radioallergosorbent (rast) Immunological 219 LLL Extractable Antinuclear Antibody, Antigen And Control 147 DHR System, Test, Rheumatoid Factor 105 JJY Multi-analyte Controls, All Kinds (assayed) 82 LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls 80 DCK C-reactive Protein, Antigen, Antiserum, And Control 78 MID System, Test, Anticardiolipin Immunological 77 DGC Ige, Antigen, Antiserum, Control 75 JZO System, Test, Thyroid Autoantibody 71 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 68 DBF Ferritin, Antigen, Antiserum, Control 68 MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca) 66 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 56 DEW Igg, Antigen, Antiserum, Control 54 JJX Single (specified) Analyte Controls (assayed And Unassayed) 50