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
226–250 of 774
Cleared Mar 16, 2006
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · Dade Behring, Inc.
DDG · Transferrin, Antigen, Antiserum, Control · 135d
Cleared Feb 13, 2006
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · Beckman Coulter, Inc.
CZP · Iga, Antigen, Antiserum, Control · 26d
Cleared Feb 07, 2006
ROCHE ELECSYS ANTI-TG
K053426 · Roche Diagnostics Corp.
JZO · System, Test, Thyroid Autoantibody · 61d
Cleared Aug 19, 2005
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K052082 · Beckman Coulter, Inc.
JMG · Radioimmunoassay (two-site Solid Phase), Ferritin · 17d
Cleared Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · Roche Diagnostics Corp.
JZO · System, Test, Thyroid Autoantibody · 23d
Cleared Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
K050231 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 161d
Cleared Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
K051185 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 58d
Cleared May 06, 2005
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
K050119 · Beckman Coulter, Inc.
JKM · Immunochemical, Bence-jones Protein · 108d
Cleared May 02, 2005
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · Dade Behring, Inc.
CZW · Complement C3, Antigen, Antiserum, Control · 48d
Cleared Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
K050387 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 69d
Cleared Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735 · Dade Behring, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 137d
Cleared Feb 08, 2005
TINA-QUANT IGG GEN.2
K050113 · Roche Diagnostics Corp.
DEW · Igg, Antigen, Antiserum, Control · 21d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 14d
Cleared Nov 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared May 10, 2004
QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO
DBF · Ferritin, Antigen, Antiserum, Control · 35d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · Roche Diagnostics Corp.
DAO · Igm (mu Chain Specific), Antigen, Antiserum, Control · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · Roche Diagnostics Corp.
DEW · Igg, Antigen, Antiserum, Control · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · Roche Diagnostics Corp.
CZP · Iga, Antigen, Antiserum, Control · 20d
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 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 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 05, 2003
N/T PROTEIN CONTROL
K032237 · Dade Behring, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 46d
Cleared Aug 07, 2003
N LATEX IGM
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 17, 2003
FERRITIN GENERATION 2
K031650 · Roche Diagnostics Corp.
DBF · Ferritin, Antigen, Antiserum, Control · 50d

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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 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 19 JJX Single (specified) Analyte Controls (assayed And Unassayed) 19 DGC Ige, Antigen, Antiserum, Control 19 DFH Kappa, Antigen, Antiserum, Control 18 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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