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.
3783
Total
3770
Cleared
227d
Avg (2y)
1976
Since
774 Immunology devices
Cleared
Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
44d
Cleared
Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
JJY
Multi-analyte Controls, All Kinds (assayed)
8d
Cleared
Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
JJS
Controls For Blood-gases, (assayed And Unassayed)
15d
Cleared
Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
JZO
System, Test, Thyroid Autoantibody
157d
Cleared
Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
DCN
System, Test, C-reactive Protein
66d
Cleared
Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
JIT
Calibrator, Secondary
87d
Cleared
Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
JJY
Multi-analyte Controls, All Kinds (assayed)
40d
Cleared
Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
LKJ
Antinuclear Antibody, Antigen, Control
45d
Cleared
May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
DHB
System, Test, Radioallergosorbent (rast) Immunological
44d
Cleared
May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
DHB
System, Test, Radioallergosorbent (rast) Immunological
44d
Cleared
Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
MOI
System, Test, Immunological, Antigen, Tumor
115d
Cleared
Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
Cleared
Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
DBI
Complement C4, Antigen, Antiserum, Control
127d
Cleared
Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
CZW
Complement C3, Antigen, Antiserum, Control
127d
Cleared
Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
DHB
System, Test, Radioallergosorbent (rast) Immunological
30d
Cleared
Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
DHB
System, Test, Radioallergosorbent (rast) Immunological
26d
Cleared
Sep 27, 2001
COLOR-MONOGEN
KTN
System, Test, Infectious Mononucleosis
29d
Cleared
Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
DDG
Transferrin, Antigen, Antiserum, Control
55d
Cleared
Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
DDG
Transferrin, Antigen, Antiserum, Control
54d
Cleared
Sep 07, 2001
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
DDC
Thyroglobulin, Antigen, Antiserum, Control
53d
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
Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
JJY
Multi-analyte Controls, All Kinds (assayed)
35d
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 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
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