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.

3794
Total
3781
Cleared
233d
Avg (2y)
1976
Since
3794 Immunology devices
551–575 of 3794
Cleared Jun 11, 2007
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
K063498 · Sebia
OBZ · Alpha-1-antitrypsin Kit, Qualitative Phenotype · 203d
Cleared May 22, 2007
EUROIMMUN ANA IFA: HEP-20-10
K070763 · Euroimmun Us, LLC
DHN · Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control · 63d
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 62d
Cleared Apr 23, 2007
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
K063766 · Good Biotech Corp.
DDG · Transferrin, Antigen, Antiserum, Control · 124d
Cleared Apr 11, 2007
QUANTA LITE RNA POL III ELISA
K070066 · Inova Diagnostics, Inc.
NYO · Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody · 93d
Cleared Apr 04, 2007
QUANTA LITE SS-A 52 ELISA
K063565 · Inova Diagnostics, Inc.
OBE · Anti-ss-a 52 Autoantibodies · 127d
Cleared Apr 02, 2007
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
K062957 · Qualigen, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 185d
Cleared Mar 20, 2007
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
K063347 · Axis-Shield Diagnostics, Ltd.
NHX · Antibodies, Anti-cyclic Citrullinated Peptide (ccp) · 134d
Cleared Mar 19, 2007
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
K063150 · Thermo Electron OY
CZW · Complement C3, Antigen, Antiserum, Control · 154d
Cleared Mar 14, 2007
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775 · Phadia US, Inc.
MST · Antibodies, Gliadin · 83d
Cleared Mar 12, 2007
QUANTA LITE H-TTG/DGP SCREEN
K070083 · Inova Diagnostics, Inc.
MST · Antibodies, Gliadin · 62d
Cleared Feb 15, 2007
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425 · Dade Behring, Inc.
DGC · Ige, Antigen, Antiserum, Control · 94d
Cleared Feb 15, 2007
DIMENSION VISTA
K063655 · Dade Behring, Inc.
CHN · Immunochemical, Ceruloplasmin · 69d
Cleared Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
K062114 · Roche Diagnostics Corp.
CHN · Immunochemical, Ceruloplasmin · 191d
Cleared Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
K062368 · Wako Chemicals USA, Inc.
OAU · Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma · 170d
Cleared Jan 26, 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
K063272 · Dade Behring, Inc.
JZG · System, Test, Beta-2-microglobulin Immunological · 88d
Cleared Jan 24, 2007
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
K063322 · Dade Behring, Inc.
DDG · Transferrin, Antigen, Antiserum, Control · 82d
Cleared Jan 11, 2007
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063610 · Dade Behring, Inc.
DEM · Alpha-1-antitrypsin, Antigen, Antiserum, Control · 38d
Cleared Dec 29, 2006
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · Phadia US, Inc.
MVM · Autoantibodies, Endomysial(tissue Transglutaminase) · 102d
Cleared Dec 26, 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · Phadia US, Inc.
MVM · Autoantibodies, Endomysial(tissue Transglutaminase) · 116d
Cleared Dec 22, 2006
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · Inova Diagnostics, Inc.
LIG · Radioassay, Intrinsic Factor Blocking Antibody · 176d
Cleared Dec 13, 2006
AESKULSKA BETA2-GLYCO-A
K062217 · Aesku, Inc.
MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 134d
Cleared Dec 13, 2006
QUANTA LITE CELIAC DGP SCREEN
K062708 · Inova Diagnostics, Inc.
MST · Antibodies, Gliadin · 93d
Cleared Dec 04, 2006
EDIA ANTI-CCP
K062045 · Euro-Diagnostica AB
NHX · Antibodies, Anti-cyclic Citrullinated Peptide (ccp) · 138d
Cleared Nov 21, 2006
FIDIS TM THYRO, MODEL MX002
K061794 · Biomedical Diagnostics (Bmd) SA
JZO · System, Test, Thyroid Autoantibody · 148d

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All categories 3794 DHB System, Test, Radioallergosorbent (rast) Immunological 256 LLL Extractable Antinuclear Antibody, Antigen And Control 181 DHR System, Test, Rheumatoid Factor 135 LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls 112 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 106 DGC Ige, Antigen, Antiserum, Control 97 DCK C-reactive Protein, Antigen, Antiserum, And Control 96 MID System, Test, Anticardiolipin Immunological 94 JZO System, Test, Thyroid Autoantibody 89 JJY Multi-analyte Controls, All Kinds (assayed) 88 DBF Ferritin, Antigen, Antiserum, Control 76 MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca) 75 DEW Igg, Antigen, Antiserum, Control 71 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 60 KTN System, Test, Infectious Mononucleosis 57