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.
3794
Total
3781
Cleared
233d
Avg (2y)
1976
Since
3794 Immunology devices
Cleared
Nov 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
MOI
System, Test, Immunological, Antigen, Tumor
132d
Cleared
Oct 28, 2002
TRUCATH.IP
DFG
Lambda, Rhodamine, Antigen, Antiserum, Control
20d
Cleared
Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
NHX
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
23d
Cleared
Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
LOJ
Kit, Test,alpha-fetoprotein For Testicular Cancer
203d
Cleared
Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
MID
System, Test, Anticardiolipin Immunological
16d
Cleared
Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
MID
System, Test, Anticardiolipin Immunological
16d
Cleared
Sep 23, 2002
CRPEX CRP CONTROLS LEVEL L, M, H
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
38d
Cleared
Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
NJF
Antibodies, Anti-actin, Anti-smooth Muscle
123d
Cleared
Sep 19, 2002
MY ALLERGY TEST
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
120d
Cleared
Sep 17, 2002
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
MSW
System, Test, Thyroglobulin
169d
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 27, 2002
APL IGA ELISA KIT
MID
System, Test, Anticardiolipin Immunological
117d
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
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
LKO
Anti-rnp Antibody, Antigen And Control
55d
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
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
MMW
System, Test, Tumor Marker, Monitoring, Bladder
103d
Cleared
Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
NIY
Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
83d
Cleared
Jul 29, 2002
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
LKP
Anti-sm Antibody, Antigen And Control
301d
Cleared
Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
DCN
System, Test, C-reactive Protein
61d
Cleared
Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
132d
Cleared
Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
NHX
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
74d
Looking for a specific immunology device? Search by device name, K-number or manufacturer.
Search all Immunology 510(k) devices