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.

3783
Total
3770
Cleared
227d
Avg (2y)
1976
Since
774 Immunology devices
201–225 of 774
Cleared Jun 25, 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · Dade Behring, Inc.
DHX · System, Test, Carcinoembryonic Antigen · 379d
Cleared Jun 04, 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc.
LOJ · Kit, Test,alpha-fetoprotein For Testicular Cancer · 358d
Cleared Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · Roche Diagnostics Corp.
DCN · System, Test, C-reactive Protein · 106d
Cleared Feb 26, 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
K073561 · Dade Behring, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 69d
Cleared Dec 21, 2007
DIMENSION VISTA C1 IN
K072965 · Dade Behring, Inc.
DBA · Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control · 60d
Cleared Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
K072612 · Beckman Coulter, Inc.
MOI · System, Test, Immunological, Antigen, Tumor · 39d
Cleared Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 55d
Cleared Aug 08, 2007
N LATEX RF KIT
K071247 · Dade Behring, Inc.
DHR · System, Test, Rheumatoid Factor · 96d
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 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 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 Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc.
JNL · Immunochemical, Thyroglobulin Autoantibody · 38d
Cleared Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 77d
Cleared Sep 22, 2006
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
K061852 · Dade Behring, Inc.
CZW · Complement C3, Antigen, Antiserum, Control · 84d
Cleared Aug 24, 2006
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K061845 · Dade Behring, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 56d
Cleared Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
K061069 · Helena Laboratories
CFF · Immunoelectrophoretic, Immunoglobulins, (g, A, M) · 80d
Cleared Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338 · Dade Behring, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 52d
Cleared Jul 06, 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382 · Beckman Coulter, Inc.
JZO · System, Test, Thyroid Autoantibody · 49d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072 · Dade Behring, Inc.
DEM · Alpha-1-antitrypsin, Antigen, Antiserum, Control · 147d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073 · Dade Behring, Inc.
DEB · Alpha-2-macroglobulin, Antigen, Antiserum, Control · 147d
Cleared Mar 16, 2006
N ANTISERA TO HUMAN CERULOPLASMIN
K053074 · Dade Behring, Inc.
DDB · Ceruloplasmin, Antigen, Antiserum, Control · 135d

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All categories 774 DHB System, Test, Radioallergosorbent (rast) Immunological 56 JJY Multi-analyte Controls, All Kinds (assayed) 33 DCK C-reactive Protein, Antigen, Antiserum, And Control 26 DHR System, Test, Rheumatoid Factor 24 DDG Transferrin, Antigen, Antiserum, Control 21 DBF Ferritin, Antigen, Antiserum, Control 21 DGC Ige, Antigen, Antiserum, Control 19 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 19 JJX Single (specified) Analyte Controls (assayed And Unassayed) 19 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 18 DFH Kappa, Antigen, Antiserum, Control 18 DEW Igg, Antigen, Antiserum, Control 17 DCN System, Test, C-reactive Protein 16 CZP Iga, Antigen, Antiserum, Control 16 JZO System, Test, Thyroid Autoantibody 15