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
May 30, 1997
QUANTA LITE IGG GLIADIN ELISA
MST
Antibodies, Gliadin
168d
Cleared
May 29, 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
JZG
System, Test, Beta-2-microglobulin Immunological
183d
Cleared
May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
JZG
System, Test, Beta-2-microglobulin Immunological
181d
Cleared
May 27, 1997
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
JNM
Immunochemical, Transferrin
90d
Cleared
May 23, 1997
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
MOI
System, Test, Immunological, Antigen, Tumor
242d
Cleared
May 23, 1997
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
DBL
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
39d
Cleared
May 21, 1997
HYCOR ALLERGEN DISC
DHB
System, Test, Radioallergosorbent (rast) Immunological
153d
Cleared
May 21, 1997
ANCA COMBI DIAGNOSTIC TEST KIT
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
149d
Cleared
May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
DDS
Prealbumin, Fitc, Antigen, Antiserum, Control
163d
Cleared
Apr 30, 1997
AURA TEK FDP
MMW
System, Test, Tumor Marker, Monitoring, Bladder
90d
Cleared
Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
DCF
Albumin, Antigen, Antiserum, Control
158d
Cleared
Apr 25, 1997
VENTANA ANTI-S100 PRIMARY ANTIBODY
DEH
Lambda, Antigen, Antiserum, Control
1123d
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 23, 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
DGC
Ige, Antigen, Antiserum, Control
189d
Cleared
Apr 22, 1997
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
DEH
Lambda, Antigen, Antiserum, Control
1135d
Cleared
Apr 21, 1997
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
DEH
Lambda, Antigen, Antiserum, Control
1111d
Cleared
Apr 21, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
MGA
Alpha-1 Microglobulin, Antigen, Antiserum, Control
125d
Cleared
Apr 17, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
JIQ
Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
121d
Cleared
Apr 17, 1997
RAICHEM RHEUMATOID FACTOR SPIA
DHR
System, Test, Rheumatoid Factor
73d
Cleared
Apr 16, 1997
BARD AND BTA TEST
MMW
System, Test, Tumor Marker, Monitoring, Bladder
197d
Cleared
Apr 10, 1997
MYELOPEROXIDASE ELISA TEST SYSTEM
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
155d
Cleared
Apr 10, 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
155d
Cleared
Apr 10, 1997
ANCA SCREEN ELISA TEST SYSTEM
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
155d
Cleared
Apr 10, 1997
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
17d
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