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
Nov 04, 1997
AXSYM CA 125
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
393d
Cleared
Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
151d
Cleared
Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
DHR
System, Test, Rheumatoid Factor
40d
Cleared
Oct 07, 1997
PRECINORM RF, PRECIPATH RF
JJY
Multi-analyte Controls, All Kinds (assayed)
13d
Cleared
Sep 29, 1997
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
DHB
System, Test, Radioallergosorbent (rast) Immunological
35d
Cleared
Sep 22, 1997
IMMULITE CEA
DHX
System, Test, Carcinoembryonic Antigen
196d
Cleared
Sep 15, 1997
AXSYM CA 15-3
MOI
System, Test, Immunological, Antigen, Tumor
350d
Cleared
Aug 22, 1997
IMMULITE 2000 PSA
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
79d
Cleared
Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
DDG
Transferrin, Antigen, Antiserum, Control
84d
Cleared
Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
JJY
Multi-analyte Controls, All Kinds (assayed)
57d
Cleared
Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
JMG
Radioimmunoassay (two-site Solid Phase), Ferritin
275d
Cleared
Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
DDR
Myoglobin, Antigen, Antiserum, Control
21d
Cleared
Jul 25, 1997
ELECSYS PSA ASSAY
LTJ
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
266d
Cleared
Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
DHR
System, Test, Rheumatoid Factor
57d
Cleared
Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
DHR
System, Test, Rheumatoid Factor
64d
Cleared
Jun 16, 1997
ELECSYS CEA ASSAY
JIT
Calibrator, Secondary
227d
Cleared
Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
CZW
Complement C3, Antigen, Antiserum, Control
190d
Cleared
Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
JIX
Calibrator, Multi-analyte Mixture
57d
Cleared
Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
DHR
System, Test, Rheumatoid Factor
20d
Cleared
Jun 02, 1997
ELECSYS FERRITIN
JMG
Radioimmunoassay (two-site Solid Phase), Ferritin
14d
Cleared
May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
DDS
Prealbumin, Fitc, Antigen, Antiserum, Control
163d
Cleared
Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
DCF
Albumin, Antigen, Antiserum, Control
158d
Cleared
Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
DDB
Ceruloplasmin, Antigen, Antiserum, Control
149d
Cleared
Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
DEM
Alpha-1-antitrypsin, Antigen, Antiserum, Control
149d
Cleared
Apr 21, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
MGA
Alpha-1 Microglobulin, Antigen, Antiserum, Control
125d
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