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
2394 Immunology devices
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
May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
NIG
System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
78d
Cleared
Apr 29, 2002
QUANTA LITE CCP ELISA
NHX
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
81d
Cleared
Apr 24, 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
LKJ
Antinuclear Antibody, Antigen, Control
19d
Cleared
Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
MOI
System, Test, Immunological, Antigen, Tumor
115d
Cleared
Mar 27, 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
LOJ
Kit, Test,alpha-fetoprotein For Testicular Cancer
15d
Cleared
Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
Cleared
Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
DBF
Ferritin, Antigen, Antiserum, Control
53d
Cleared
Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
39d
Cleared
Jan 02, 2002
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
DBY
Fab, Rhodamine, Antigen, Antiserum, Control
90d
Cleared
Dec 21, 2001
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
DHX
System, Test, Carcinoembryonic Antigen
56d
Cleared
Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
46d
Cleared
Dec 14, 2001
GORE INTRODUCER SHEATH
DBY
Fab, Rhodamine, Antigen, Antiserum, Control
73d
Cleared
Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
DBY
Fab, Rhodamine, Antigen, Antiserum, Control
23d
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
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