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.
3792
Total
3779
Cleared
232d
Avg (2y)
1976
Since
3125 Immunology devices
Cleared
Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
MID
System, Test, Anticardiolipin Immunological
49d
Cleared
Aug 20, 2001
POLYTITER SYSTEM
DHN
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
40d
Cleared
Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
31d
Cleared
Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
31d
Cleared
Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
MOI
System, Test, Immunological, Antigen, Tumor
153d
Cleared
Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
JIT
Calibrator, Secondary
180d
Cleared
Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
DDG
Transferrin, Antigen, Antiserum, Control
62d
Cleared
Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
62d
Cleared
Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
LLL
Extractable Antinuclear Antibody, Antigen And Control
105d
Cleared
Jul 25, 2001
K-ASSAY C1-INA
DBA
Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
48d
Cleared
Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
JJY
Multi-analyte Controls, All Kinds (assayed)
34d
Cleared
Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
49d
Cleared
Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
49d
Cleared
Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
JJY
Multi-analyte Controls, All Kinds (assayed)
35d
Cleared
Jun 25, 2001
WAKO AUTOKIT C4
DBI
Complement C4, Antigen, Antiserum, Control
143d
Cleared
Jun 25, 2001
WAKO AUTOKIT C3
CZW
Complement C3, Antigen, Antiserum, Control
143d
Cleared
Jun 25, 2001
WAKO LIPID CALIBRATOR
JIT
Calibrator, Secondary
143d
Cleared
Jun 18, 2001
IBD-CHEK
DEG
Lactoferrin, Antigen, Antiserum, Control
42d
Cleared
Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
24d
Cleared
May 30, 2001
ALPCO MILENIA ANTI-TG EIA
JZO
System, Test, Thyroid Autoantibody
22d
Cleared
May 24, 2001
ALPCO MILENIA ANTI-TPO ELISA
JZO
System, Test, Thyroid Autoantibody
35d
Cleared
May 21, 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
NBT
Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
441d
Cleared
May 16, 2001
K-ASSAY HS-CRP CONTROLS
DCK
C-reactive Protein, Antigen, Antiserum, And Control
37d
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
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