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.
3792
Total
3779
Cleared
232d
Avg (2y)
1976
Since
3125 Immunology devices
Cleared
Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
95d
Not Cleared
Aug 16, 2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
NBT
Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
29d
Cleared
Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
JIS
Calibrator, Primary
8d
Cleared
Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
DCK
C-reactive Protein, Antigen, Antiserum, And Control
128d
Cleared
Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
28d
Cleared
Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
28d
Cleared
Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
28d
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 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
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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