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 15, 2001
RANDOX IGE
DGC
Ige, Antigen, Antiserum, Control
54d
Cleared
May 10, 2001
CRP HS TEST SYSTEM
DCN
System, Test, C-reactive Protein
190d
Cleared
May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
JIS
Calibrator, Primary
63d
Cleared
May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
DDG
Transferrin, Antigen, Antiserum, Control
211d
Cleared
Apr 26, 2001
FREELITE LAMBDA FREE KIT
DEH
Lambda, Antigen, Antiserum, Control
72d
Cleared
Apr 26, 2001
FREELITE KAPPA FREE KIT
DEH
Lambda, Antigen, Antiserum, Control
72d
Cleared
Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
57d
Cleared
Apr 24, 2001
EUROSPITAL EU-TTG IGA UMANA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
53d
Cleared
Apr 11, 2001
VIGIL DNASE B CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
34d
Cleared
Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
DHC
System, Test, Systemic Lupus Erythematosus
346d
Cleared
Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
DCK
C-reactive Protein, Antigen, Antiserum, And Control
70d
Cleared
Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
MLE
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
36d
Cleared
Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
DHC
System, Test, Systemic Lupus Erythematosus
331d
Cleared
Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
MOI
System, Test, Immunological, Antigen, Tumor
29d
Cleared
Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
DBA
Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
105d
Cleared
Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
44d
Cleared
Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
DEW
Igg, Antigen, Antiserum, Control
14d
Cleared
Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
35d
Cleared
Mar 05, 2001
VIGIL SEROLOGY CONTROL LEVEL C
JJY
Multi-analyte Controls, All Kinds (assayed)
27d
Cleared
Mar 01, 2001
ENA EIA KIT RANGE
LLL
Extractable Antinuclear Antibody, Antigen And Control
43d
Cleared
Mar 01, 2001
ENA EIA KIT
LLL
Extractable Antinuclear Antibody, Antigen And Control
43d
Cleared
Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
68d
Cleared
Feb 23, 2001
ENA SCREEN EIA KIT
LLL
Extractable Antinuclear Antibody, Antigen And Control
37d
Cleared
Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
50d
Cleared
Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
DCN
System, Test, C-reactive Protein
104d
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