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
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
Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
81d
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
Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
66d
Cleared
Jun 02, 2003
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
DCK
C-reactive Protein, Antigen, Antiserum, And Control
102d
Cleared
Jun 02, 2003
CRP (II) CALIBRATORS
JIS
Calibrator, Primary
102d
Cleared
May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
16d
Cleared
May 12, 2003
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
LKJ
Antinuclear Antibody, Antigen, Control
62d
Cleared
May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
DHX
System, Test, Carcinoembryonic Antigen
15d
Cleared
May 02, 2003
ANA DETECT
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
39d
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
May 01, 2003
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
MID
System, Test, Anticardiolipin Immunological
52d
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
Apr 11, 2003
RDI EXTENDED RANGE CRP CALIBRATOR SET
JIT
Calibrator, Secondary
31d
Cleared
Mar 24, 2003
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
DBM
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
60d
Cleared
Mar 21, 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
43d
Cleared
Mar 21, 2003
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
DHB
System, Test, Radioallergosorbent (rast) Immunological
24d
Cleared
Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
DCK
C-reactive Protein, Antigen, Antiserum, And Control
19d
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