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
Cleared
Sep 25, 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
NHX
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
270d
Not Cleared
Sep 11, 2009
OVA1 TEST
ONX
Ovarian Adnexal Mass Assessment Score Test System
51d
Cleared
Sep 03, 2009
KAPPA LIGHT CHAINS
DFH
Kappa, Antigen, Antiserum, Control
272d
Cleared
Sep 03, 2009
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
JZO
System, Test, Thyroid Autoantibody
164d
Cleared
Aug 07, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
MST
Antibodies, Gliadin
297d
Cleared
Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
DHB
System, Test, Radioallergosorbent (rast) Immunological
97d
Cleared
Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
MST
Antibodies, Gliadin
287d
Cleared
Jun 22, 2009
VIDAS CA 15-3 ASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
487d
Cleared
Jun 22, 2009
LAMBDA LIGHT CHAINS
DEH
Lambda, Antigen, Antiserum, Control
199d
Cleared
May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
LKO
Anti-rnp Antibody, Antigen And Control
218d
Cleared
May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
DHB
System, Test, Radioallergosorbent (rast) Immunological
113d
Cleared
May 21, 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
JZO
System, Test, Thyroid Autoantibody
185d
Cleared
May 20, 2009
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
147d
Cleared
May 06, 2009
HUMAN BETA-2 MICROGLOBULIN KIT
JZG
System, Test, Beta-2-microglobulin Immunological
180d
Cleared
Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
55d
Cleared
Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
LOJ
Kit, Test,alpha-fetoprotein For Testicular Cancer
84d
Cleared
Apr 17, 2009
CAPILLARYS IMMUNOTYPING, MODEL 2100
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
268d
Cleared
Apr 15, 2009
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
LRM
Anti-dna Antibody (enzyme-labeled), Antigen, Control
152d
Cleared
Apr 14, 2009
MINICAP IMMUNOTYPING, MODEL: 2300
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
238d
Cleared
Apr 10, 2009
VIDAS CA 125 II ASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
407d
Cleared
Apr 10, 2009
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
LKJ
Antinuclear Antibody, Antigen, Control
200d
Cleared
Apr 07, 2009
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
252d
Cleared
Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
123d
Cleared
Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
DHB
System, Test, Radioallergosorbent (rast) Immunological
90d
Cleared
Mar 18, 2009
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
DHX
System, Test, Carcinoembryonic Antigen
282d
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