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.

3787
Total
3774
Cleared
236d
Avg (2y)
1976
Since
2394 Immunology devices
426–450 of 2394
Cleared Oct 27, 2005
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K043341 · Bio-Rad Laboratories, Inc.
NVI · Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease · 328d
Cleared Oct 27, 2005
QUANTA LITE M2 EP (MIT3) ELISA
K052262 · Inova Diagnostics, Inc.
DBM · Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control · 69d
Cleared Oct 25, 2005
ARCHITECT CA 19-9XR ASSAY
K052000 · Fujirebio Diagnostics,Inc.
NIG · System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer · 92d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGG II
K052142 · Inova Diagnostics, Inc.
MST · Antibodies, Gliadin · 57d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc.
MST · Antibodies, Gliadin · 57d
Cleared Sep 06, 2005
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
K051915 · The Binding Site, Ltd.
DFH · Kappa, Antigen, Antiserum, Control · 53d
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 Jun 13, 2005
QUANTA LITE SP100 ELISA
K050662 · Inova Diagnostics, Inc.
NUM · Autoantibodies, Nuclear Body Protein, Sp100 · 90d
Not Cleared May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
DEN050002 · Wako Chemicals USA, Inc.
NSF · Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment · 42d
Cleared May 12, 2005
QUANTA PLEX ANCA PROFILE
K050715 · Inova Diagnostics, Inc.
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 55d
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 28, 2005
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272 · ACON Laboratories, Inc.
KTN · System, Test, Infectious Mononucleosis · 189d
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 Dec 22, 2004
ARCHITECT CA 15-3 ASSAY
K042732 · Fujirebio Diagnostics,Inc.
MOI · System, Test, Immunological, Antigen, Tumor · 82d
Cleared Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
K041658 · Bio-Rad Laboratories, Inc.
LKJ · Antinuclear Antibody, Antigen, Control · 185d
Cleared Dec 10, 2004
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241 · Kamiya Biomedical Co.
DGC · Ige, Antigen, Antiserum, Control · 113d
Cleared Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · Bio-Rad Laboratories, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 14d
Cleared Nov 19, 2004
ARCHITECT CA 125 II ASSAY
K042731 · Fujirebio Diagnostics,Inc.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 49d

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All categories 2394 DHB System, Test, Radioallergosorbent (rast) Immunological 175 LLL Extractable Antinuclear Antibody, Antigen And Control 116 DHR System, Test, Rheumatoid Factor 77 JJY Multi-analyte Controls, All Kinds (assayed) 69 DGC Ige, Antigen, Antiserum, Control 67 DCK C-reactive Protein, Antigen, Antiserum, And Control 62 DBF Ferritin, Antigen, Antiserum, Control 56 DEW Igg, Antigen, Antiserum, Control 51 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 51 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 51 MID System, Test, Anticardiolipin Immunological 46 JJX Single (specified) Analyte Controls (assayed And Unassayed) 44 DEH Lambda, Antigen, Antiserum, Control 42 DFH Kappa, Antigen, Antiserum, Control 39 JZO System, Test, Thyroid Autoantibody 39