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
Jul 23, 2000
WAKO AUTOKIT LP(A)/DADE DEMENSION
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
30d
Cleared
Jul 23, 2000
WAKO AUTOKIT LP(A)/ RA,500/1000,
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
30d
Cleared
Jul 23, 2000
WAKO AUTOKIT LP(A)/EXPRESS 550
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
30d
Cleared
Jun 28, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
182d
Cleared
Jun 09, 2000
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
NBO
Autoantibodies, Skin (desmoglein 1 And Desmoglein 3)
127d
Cleared
Jun 09, 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
MID
System, Test, Anticardiolipin Immunological
18d
Cleared
Jun 07, 2000
QUANTA LITE LKM-1 ELISA
NBS
Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1)
111d
Cleared
Jun 07, 2000
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
MST
Antibodies, Gliadin
35d
Cleared
Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
64d
Cleared
May 22, 2000
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
63d
Cleared
May 22, 2000
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
63d
Cleared
May 18, 2000
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
44d
Cleared
May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
JZO
System, Test, Thyroid Autoantibody
119d
Cleared
May 09, 2000
RHIGENE MESACUP2 TEST- SSA
LLL
Extractable Antinuclear Antibody, Antigen And Control
62d
Cleared
May 09, 2000
RHIGENE MESACUP2 TEST- SCL-70
LLL
Extractable Antinuclear Antibody, Antigen And Control
62d
Cleared
May 09, 2000
RHIGENE MESACUP2 TEST- SSB
LLL
Extractable Antinuclear Antibody, Antigen And Control
62d
Cleared
May 09, 2000
RHIGENE MESACUP2 TEST- RNP
LKO
Anti-rnp Antibody, Antigen And Control
62d
Cleared
May 09, 2000
RHIGENE MESACUP2 TEST- SM
LKP
Anti-sm Antibody, Antigen And Control
62d
Cleared
May 09, 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
MSW
System, Test, Thyroglobulin
153d
Cleared
May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
345d
Cleared
May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
345d
Cleared
May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
345d
Cleared
May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
345d
Cleared
Apr 27, 2000
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
57d
Cleared
Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
29d
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