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
Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
104d
Cleared
Dec 18, 2002
ST AIA-PACK CEA ENZYME IMMUNOASSAY
DHX
System, Test, Carcinoembryonic Antigen
26d
Cleared
Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
155d
Cleared
Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
DHB
System, Test, Radioallergosorbent (rast) Immunological
85d
Cleared
Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
LOJ
Kit, Test,alpha-fetoprotein For Testicular Cancer
25d
Cleared
Dec 13, 2002
K-ASSAY LP(A) CONTROLS
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
24d
Cleared
Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
44d
Cleared
Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
14d
Cleared
Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
NJF
Antibodies, Anti-actin, Anti-smooth Muscle
123d
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
Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
DBY
Fab, Rhodamine, Antigen, Antiserum, Control
78d
Cleared
Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
DHR
System, Test, Rheumatoid Factor
167d
Cleared
Aug 15, 2002
MININEPH HUMAN B2-MICROGLOBULIN KIT
JZG
System, Test, Beta-2-microglobulin Immunological
231d
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 14, 2002
K-ASSAY HS-CRP CONTROLS
DCK
C-reactive Protein, Antigen, Antiserum, And Control
16d
Cleared
Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
JZO
System, Test, Thyroid Autoantibody
157d
Cleared
Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
NIY
Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
83d
Cleared
Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
132d
Cleared
Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
DCN
System, Test, C-reactive Protein
66d
Cleared
Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
JJY
Multi-analyte Controls, All Kinds (assayed)
22d
Cleared
Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
20d
Cleared
Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
DHR
System, Test, Rheumatoid Factor
68d
Cleared
Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
JIT
Calibrator, Secondary
87d
Cleared
Jun 17, 2002
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
DFZ
Igg (gamma Chain Specific), Antigen, Antiserum, Control
75d
Cleared
Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
JJY
Multi-analyte Controls, All Kinds (assayed)
40d
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