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 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
385d
Cleared
Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
151d
Cleared
Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
MID
System, Test, Anticardiolipin Immunological
64d
Cleared
Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
DBF
Ferritin, Antigen, Antiserum, Control
48d
Cleared
Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
DHR
System, Test, Rheumatoid Factor
40d
Cleared
Oct 20, 1997
VENTANA CD45 PRIMARY ANTIBODY
DEH
Lambda, Antigen, Antiserum, Control
1350d
Cleared
Oct 20, 1997
N ANTISERUM TO HUMAN ALBUMIN
DCF
Albumin, Antigen, Antiserum, Control
73d
Cleared
Oct 20, 1997
QUANTA LITE B2 GPI IGA
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
68d
Cleared
Oct 20, 1997
QUANTA LITE B2GPI IGM
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
68d
Cleared
Oct 17, 1997
N ANTISERUM TO HUMAN TRANSFERRIN
DDG
Transferrin, Antigen, Antiserum, Control
77d
Cleared
Oct 07, 1997
PRECINORM RF, PRECIPATH RF
JJY
Multi-analyte Controls, All Kinds (assayed)
13d
Cleared
Oct 03, 1997
AIA-PACK IGE II ASSAY
DGC
Ige, Antigen, Antiserum, Control
77d
Cleared
Oct 03, 1997
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
85d
Cleared
Oct 03, 1997
CHEMMATE L26 (CD20)
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
85d
Cleared
Oct 03, 1997
CHEMMATE KAPPA
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
85d
Cleared
Oct 03, 1997
CHEMMATE LAMBDA
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
86d
Cleared
Sep 29, 1997
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
DHB
System, Test, Radioallergosorbent (rast) Immunological
35d
Cleared
Sep 29, 1997
RETINOL BINDING PROTEIN RBP RID KIT
CZS
Retinol-binding Protein, Antigen, Antiserum, Control
35d
Cleared
Sep 25, 1997
WAKO CH50 LINEARITY SET
JIW
Calibrator, Surrogate
41d
Cleared
Sep 25, 1997
CHEMMATE LCA
DEH
Lambda, Antigen, Antiserum, Control
86d
Cleared
Sep 22, 1997
IMMULITE CEA
DHX
System, Test, Carcinoembryonic Antigen
196d
Cleared
Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
LOJ
Kit, Test,alpha-fetoprotein For Testicular Cancer
83d
Cleared
Sep 15, 1997
AXSYM CA 15-3
MOI
System, Test, Immunological, Antigen, Tumor
350d
Cleared
Sep 12, 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
DBF
Ferritin, Antigen, Antiserum, Control
66d
Cleared
Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
DHR
System, Test, Rheumatoid Factor
89d
Looking for a specific immunology device? Search by device name, K-number or manufacturer.
Search all Immunology 510(k) devices