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
Dec 29, 2003
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
NIG
System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
91d
Cleared
Dec 24, 2003
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
126d
Cleared
Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
MID
System, Test, Anticardiolipin Immunological
70d
Cleared
Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
DAK
Complement C1q, Antigen, Antiserum, Control
114d
Cleared
Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
DHR
System, Test, Rheumatoid Factor
23d
Cleared
Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
187d
Cleared
Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
187d
Cleared
Sep 05, 2003
N/T PROTEIN CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
46d
Cleared
Aug 07, 2003
N LATEX IGM
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
38d
Cleared
Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
CZW
Complement C3, Antigen, Antiserum, Control
37d
Cleared
Jul 23, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
JJY
Multi-analyte Controls, All Kinds (assayed)
64d
Cleared
Jul 17, 2003
FERRITIN GENERATION 2
DBF
Ferritin, Antigen, Antiserum, Control
50d
Cleared
Jul 15, 2003
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
DEH
Lambda, Antigen, Antiserum, Control
106d
Cleared
Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
LLL
Extractable Antinuclear Antibody, Antigen And Control
49d
Cleared
Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
NIG
System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
53d
Cleared
May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
16d
Cleared
May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
DHX
System, Test, Carcinoembryonic Antigen
15d
Cleared
May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
MSW
System, Test, Thyroglobulin
11d
Cleared
May 02, 2003
ACCESS OV MONITOR ASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
8d
Cleared
Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
LLL
Extractable Antinuclear Antibody, Antigen And Control
50d
Cleared
Apr 21, 2003
IBD-QUIK CHEK
DEG
Lactoferrin, Antigen, Antiserum, Control
46d
Cleared
Mar 24, 2003
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
DBM
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
60d
Cleared
Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
DCK
C-reactive Protein, Antigen, Antiserum, And Control
19d
Cleared
Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
DGC
Ige, Antigen, Antiserum, Control
66d
Cleared
Feb 24, 2003
BIORAPID MONONUCLEOSIS
KTN
System, Test, Infectious Mononucleosis
34d
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