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
Cleared
Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
JZO
System, Test, Thyroid Autoantibody
63d
Cleared
Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
DHB
System, Test, Radioallergosorbent (rast) Immunological
30d
Cleared
Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
DHB
System, Test, Radioallergosorbent (rast) Immunological
26d
Cleared
Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
MST
Antibodies, Gliadin
38d
Cleared
Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
MST
Antibodies, Gliadin
38d
Cleared
Sep 27, 2001
COLOR-MONOGEN
KTN
System, Test, Infectious Mononucleosis
29d
Cleared
Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
DDG
Transferrin, Antigen, Antiserum, Control
55d
Cleared
Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
DDG
Transferrin, Antigen, Antiserum, Control
54d
Cleared
Sep 07, 2001
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
DDC
Thyroglobulin, Antigen, Antiserum, Control
53d
Cleared
Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
42d
Cleared
Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
42d
Cleared
Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
MID
System, Test, Anticardiolipin Immunological
49d
Cleared
Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
31d
Cleared
Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
31d
Cleared
Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
MOI
System, Test, Immunological, Antigen, Tumor
153d
Cleared
Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
JIT
Calibrator, Secondary
180d
Cleared
Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
DDG
Transferrin, Antigen, Antiserum, Control
62d
Cleared
Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
62d
Cleared
Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
LLL
Extractable Antinuclear Antibody, Antigen And Control
105d
Cleared
Jul 25, 2001
K-ASSAY C1-INA
DBA
Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
48d
Cleared
Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
JJY
Multi-analyte Controls, All Kinds (assayed)
34d
Cleared
Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
49d
Cleared
Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
49d
Cleared
Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
JJY
Multi-analyte Controls, All Kinds (assayed)
35d
Cleared
Jun 25, 2001
WAKO AUTOKIT C4
DBI
Complement C4, Antigen, Antiserum, Control
143d
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