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
2393 Immunology devices
Cleared
Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
MOI
System, Test, Immunological, Antigen, Tumor
39d
Cleared
Sep 24, 2007
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
LIG
Radioassay, Intrinsic Factor Blocking Antibody
133d
Cleared
Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
JJY
Multi-analyte Controls, All Kinds (assayed)
55d
Cleared
Aug 08, 2007
N LATEX RF KIT
DHR
System, Test, Rheumatoid Factor
96d
Cleared
Jul 03, 2007
LIQUICHEK TUMOR MARKER CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
14d
Cleared
Jun 21, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
DFH
Kappa, Antigen, Antiserum, Control
311d
Cleared
Jun 20, 2007
QUANTA PLEX CELIAC IGA PROFILE
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
180d
Cleared
Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
JIT
Calibrator, Secondary
62d
Cleared
Apr 11, 2007
QUANTA LITE RNA POL III ELISA
NYO
Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
93d
Cleared
Apr 04, 2007
QUANTA LITE SS-A 52 ELISA
OBE
Anti-ss-a 52 Autoantibodies
127d
Cleared
Mar 12, 2007
QUANTA LITE H-TTG/DGP SCREEN
MST
Antibodies, Gliadin
62d
Cleared
Feb 15, 2007
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
DGC
Ige, Antigen, Antiserum, Control
94d
Cleared
Feb 15, 2007
DIMENSION VISTA
CHN
Immunochemical, Ceruloplasmin
69d
Cleared
Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
CHN
Immunochemical, Ceruloplasmin
191d
Cleared
Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
OAU
Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma
170d
Cleared
Jan 26, 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
JZG
System, Test, Beta-2-microglobulin Immunological
88d
Cleared
Jan 24, 2007
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
DDG
Transferrin, Antigen, Antiserum, Control
82d
Cleared
Jan 11, 2007
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
38d
Cleared
Dec 22, 2006
QUANTA LITE INTRINSIC FACTOR ELISA
LIG
Radioassay, Intrinsic Factor Blocking Antibody
176d
Cleared
Dec 13, 2006
QUANTA LITE CELIAC DGP SCREEN
MST
Antibodies, Gliadin
93d
Cleared
Nov 21, 2006
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
LRM
Anti-dna Antibody (enzyme-labeled), Antigen, Control
113d
Cleared
Oct 18, 2006
QUANTA LITE PBC SCREEN IGG/IGA ELISA
NRI
Autoantibodies, Nuclear Pore Glycoprotein Gp210
111d
Cleared
Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
JNL
Immunochemical, Thyroglobulin Autoantibody
38d
Cleared
Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
JIX
Calibrator, Multi-analyte Mixture
77d
Cleared
Sep 22, 2006
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
CZW
Complement C3, Antigen, Antiserum, Control
84d
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