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
Jun 13, 2005
QUANTA LITE SP100 ELISA
NUM
Autoantibodies, Nuclear Body Protein, Sp100
90d
Cleared
Jun 09, 2005
MODIFICATION TO: UNICAP SPECIFIC IGE
DHB
System, Test, Radioallergosorbent (rast) Immunological
28d
Cleared
Jun 01, 2005
AESKULISA TTG A AND AESKULISA TTG G
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
247d
Cleared
May 31, 2005
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
LLL
Extractable Antinuclear Antibody, Antigen And Control
204d
Not Cleared
May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
NSF
Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
42d
Cleared
May 13, 2005
QUANTIA A1-AT
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
66d
Cleared
May 12, 2005
QUANTA PLEX ANCA PROFILE
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
55d
Cleared
May 06, 2005
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
JKM
Immunochemical, Bence-jones Protein
108d
Cleared
May 02, 2005
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
CZW
Complement C3, Antigen, Antiserum, Control
48d
Cleared
Apr 26, 2005
VARELISA RECOMBI ANA PROFILE, MODEL 18496
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
46d
Cleared
Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
JJY
Multi-analyte Controls, All Kinds (assayed)
69d
Cleared
Mar 07, 2005
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
84d
Cleared
Feb 28, 2005
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
KTN
System, Test, Infectious Mononucleosis
189d
Cleared
Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
137d
Cleared
Feb 08, 2005
TINA-QUANT IGG GEN.2
DEW
Igg, Antigen, Antiserum, Control
21d
Cleared
Dec 22, 2004
ARCHITECT CA 15-3 ASSAY
MOI
System, Test, Immunological, Antigen, Tumor
82d
Cleared
Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
LKJ
Antinuclear Antibody, Antigen, Control
185d
Cleared
Dec 17, 2004
KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
NST
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking
120d
Cleared
Dec 10, 2004
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
DGC
Ige, Antigen, Antiserum, Control
113d
Cleared
Dec 08, 2004
VARELISA SM ANTIBODIES, MODEL 18296
LKP
Anti-sm Antibody, Antigen And Control
72d
Cleared
Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
28d
Cleared
Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
JIT
Calibrator, Secondary
14d
Cleared
Nov 22, 2004
BINDING SITE IGG SUBLCASS OLYMPUS KITS
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
105d
Cleared
Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
51d
Cleared
Nov 19, 2004
ARCHITECT CA 125 II ASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
49d
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