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
Feb 03, 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
MOI
System, Test, Immunological, Antigen, Tumor
127d
Cleared
Jan 30, 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
DEH
Lambda, Antigen, Antiserum, Control
52d
Cleared
Jan 22, 2004
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
JZG
System, Test, Beta-2-microglobulin Immunological
142d
Cleared
Jan 22, 2004
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
MMW
System, Test, Tumor Marker, Monitoring, Bladder
30d
Cleared
Jan 20, 2004
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
50d
Cleared
Jan 13, 2004
IBL C3D-CIC EIA TEST
CZW
Complement C3, Antigen, Antiserum, Control
127d
Cleared
Jan 08, 2004
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
LKJ
Antinuclear Antibody, Antigen, Control
15d
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
Dec 22, 2003
MESACUP-2 TEST JO-1, MODEL 10756
LLL
Extractable Antinuclear Antibody, Antigen And Control
45d
Cleared
Dec 19, 2003
IMMUNETECH TOTAL IGE SYSTEM
DGC
Ige, Antigen, Antiserum, Control
150d
Cleared
Dec 16, 2003
AESKULISA ANA 8PRO
LLL
Extractable Antinuclear Antibody, Antigen And Control
127d
Cleared
Nov 19, 2003
INTERLAB IMMUNOFIXATION TEST(S)
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
49d
Cleared
Nov 04, 2003
HYDRAGEL CSF ISOFOCUSING KITS
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
25d
Cleared
Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
MID
System, Test, Anticardiolipin Immunological
29d
Cleared
Oct 10, 2003
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
DCK
C-reactive Protein, Antigen, Antiserum, And Control
141d
Cleared
Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
MID
System, Test, Anticardiolipin Immunological
70d
Cleared
Sep 26, 2003
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
DBM
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
155d
Cleared
Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
DAK
Complement C1q, Antigen, Antiserum, Control
114d
Cleared
Sep 10, 2003
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
JZO
System, Test, Thyroid Autoantibody
61d
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 29, 2003
IBL C1Q-CIC CIA TEST
DAK
Complement C1q, Antigen, Antiserum, Control
38d
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