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
May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
205d
Cleared
May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
193d
Cleared
May 14, 1999
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2
DHB
System, Test, Radioallergosorbent (rast) Immunological
45d
Cleared
May 14, 1999
K-ASSAY CRP
DCK
C-reactive Protein, Antigen, Antiserum, And Control
32d
Cleared
May 13, 1999
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
JZO
System, Test, Thyroid Autoantibody
42d
Cleared
May 13, 1999
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
JZO
System, Test, Thyroid Autoantibody
42d
Cleared
May 11, 1999
ABBOTT ARCHITECT CEA
DHX
System, Test, Carcinoembryonic Antigen
63d
Cleared
May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
JZG
System, Test, Beta-2-microglobulin Immunological
36d
Cleared
May 11, 1999
K-ASSAY CRP CALIBRATOR SET
DCK
C-reactive Protein, Antigen, Antiserum, And Control
32d
Cleared
May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
DCK
C-reactive Protein, Antigen, Antiserum, And Control
60d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-SM/RNP ELISA
LKO
Anti-rnp Antibody, Antigen And Control
62d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-SM ELISA
LKP
Anti-sm Antibody, Antigen And Control
62d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-SS-B/LA ELISA
LLL
Extractable Antinuclear Antibody, Antigen And Control
62d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-SS-A/RO ELISA
LLL
Extractable Antinuclear Antibody, Antigen And Control
62d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
49d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-SCL-70 ELISA
LLL
Extractable Antinuclear Antibody, Antigen And Control
49d
Cleared
Apr 28, 1999
AUTOSTAT II ANTI-JO-1 ELISA
LLL
Extractable Antinuclear Antibody, Antigen And Control
49d
Cleared
Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
34d
Cleared
Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
KTL
Anti-dna Indirect Immunofluorescent Solid Phase
34d
Cleared
Apr 16, 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
JIT
Calibrator, Secondary
35d
Cleared
Apr 16, 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
DCN
System, Test, C-reactive Protein
35d
Cleared
Apr 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
15d
Cleared
Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
DHR
System, Test, Rheumatoid Factor
43d
Cleared
Apr 06, 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
DCK
C-reactive Protein, Antigen, Antiserum, And Control
20d
Cleared
Mar 26, 1999
GLIADIN IGG ELISA TEST SYSTEM
MST
Antibodies, Gliadin
64d
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