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
3126 Immunology devices
1276–1300 of 3126
Cleared Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189 · Boehringer Mannheim Corp.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 60d
Cleared Dec 12, 1997
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
K971905 · Dako Corp.
DEH · Lambda, Antigen, Antiserum, Control · 203d
Cleared Dec 05, 1997
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
K972790 · Theratest Laboratories, Inc.
MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 130d
Cleared Dec 05, 1997
EL-B2GP1SCR
K973882 · Theratest Laboratories, Inc.
MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 52d
Cleared Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · Bayer Corp.
MOI · System, Test, Immunological, Antigen, Tumor · 374d
Cleared Dec 01, 1997
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc.,
KTN · System, Test, Infectious Mononucleosis · 153d
Cleared Nov 25, 1997
RHEUMACOL RHEUMATOID FACTOR TEST
K972456 · Immunostics Inc.,
DHR · System, Test, Rheumatoid Factor · 147d
Cleared Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050 · Beckman Instruments, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 31d
Cleared Nov 21, 1997
ELECSYS AFP
K973351 · Boehringer Mannheim Corp.
LOJ · Kit, Test,alpha-fetoprotein For Testicular Cancer · 77d
Cleared Nov 20, 1997
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · Beckman Instruments, Inc.
JZG · System, Test, Beta-2-microglobulin Immunological · 44d
Cleared Nov 13, 1997
VIRGO ANCA SCREEN KIT
K973822 · Hemagen Diagnostics, Inc.
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 37d
Cleared Nov 13, 1997
PR 3 ANTIBODY KIT
K973823 · Hemagen Diagnostics, Inc.
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 37d
Cleared Nov 13, 1997
VIRGO PANCO KIT
K973824 · Hemagen Diagnostics, Inc.
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 37d
Cleared Nov 10, 1997
IMX CA 15-3
K964407 · Abbott Laboratories
MOI · System, Test, Immunological, Antigen, Tumor · 371d
Cleared Nov 10, 1997
APO-TEK LP(A)
K970302 · Perimmune, Inc.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 287d
Cleared Nov 06, 1997
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
K965022 · Dako Corp.
DEH · Lambda, Antigen, Antiserum, Control · 325d
Cleared Nov 04, 1997
AXSYM CA 125
K964020 · Abbott Laboratories
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 393d
Cleared Nov 04, 1997
IMX CA 125
K964185 · Abbott Diagnostics
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 379d
Cleared Oct 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964098 · Bayer Corp.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 385d
Cleared Oct 31, 1997
TRUQUANT BR RIA
K965141 · Biomira USA, Inc.
MOI · System, Test, Immunological, Antigen, Tumor · 312d
Cleared Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · Diagnostic Products Corp.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 151d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
K971464 · Euro-Diagnostica AB
DBL · Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control · 190d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
K971689 · Euro-Diagnostica AB
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 175d
Cleared Oct 29, 1997
IMMUNOSCAN PR3-ANCA
K971690 · Euro-Diagnostica AB
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 175d
Cleared Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196 · Zeus Scientific, Inc.
MID · System, Test, Anticardiolipin Immunological · 64d

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All categories 3126 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 DBF Ferritin, Antigen, Antiserum, Control 68 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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