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
Dec 10, 2001
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
LKJ
Antinuclear Antibody, Antigen, Control
231d
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
Nov 29, 2001
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
KTL
Anti-dna Indirect Immunofluorescent Solid Phase
45d
Cleared
Nov 20, 2001
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
JJY
Multi-analyte Controls, All Kinds (assayed)
42d
Cleared
Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
43d
Cleared
Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
43d
Cleared
Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
MID
System, Test, Anticardiolipin Immunological
86d
Cleared
Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
MID
System, Test, Anticardiolipin Immunological
86d
Cleared
Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
JZO
System, Test, Thyroid Autoantibody
63d
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 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
MST
Antibodies, Gliadin
38d
Cleared
Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
MST
Antibodies, Gliadin
38d
Cleared
Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
14d
Cleared
Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
14d
Cleared
Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
14d
Cleared
Sep 27, 2001
COLOR-MONOGEN
KTN
System, Test, Infectious Mononucleosis
29d
Cleared
Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
MID
System, Test, Anticardiolipin Immunological
13d
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
Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
42d
Cleared
Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
42d
Cleared
Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
MID
System, Test, Anticardiolipin Immunological
14d
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