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.
3792
Total
3779
Cleared
232d
Avg (2y)
1976
Since
3124 Immunology devices
Cleared
Aug 17, 2012
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
DCN
System, Test, C-reactive Protein
238d
Cleared
Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
MOB
Test System, Antineutrophil Cytoplasmic Antibodies (anca)
334d
Cleared
Jul 11, 2012
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
DAE
Complement C9, Antigen, Antiserum, Control
240d
Cleared
Jul 09, 2012
ANA-SCREEN WITH MDSS
LKJ
Antinuclear Antibody, Antigen, Control
216d
Cleared
Jun 26, 2012
THE HELENA V8 IMMUNODISPLACEMENT KIT
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
407d
Cleared
Jun 22, 2012
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
MSV
System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
305d
Cleared
May 30, 2012
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
PAF
Voltage Gated Calcium Channel (vgcc) Antibody Assay
324d
Cleared
May 24, 2012
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
DBF
Ferritin, Antigen, Antiserum, Control
30d
Cleared
Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
MID
System, Test, Anticardiolipin Immunological
456d
Cleared
Feb 27, 2012
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
424d
Not Cleared
Feb 15, 2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
OYL
Tryptase Assay System
34d
Cleared
Jan 24, 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
130d
Cleared
Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
JZG
System, Test, Beta-2-microglobulin Immunological
297d
Cleared
Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
DHB
System, Test, Radioallergosorbent (rast) Immunological
128d
Cleared
Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
JNL
Immunochemical, Thyroglobulin Autoantibody
85d
Cleared
Dec 22, 2011
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
DHB
System, Test, Radioallergosorbent (rast) Immunological
168d
Cleared
Dec 12, 2011
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
MID
System, Test, Anticardiolipin Immunological
474d
Cleared
Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
LLL
Extractable Antinuclear Antibody, Antigen And Control
38d
Cleared
Nov 07, 2011
IT/IF CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
493d
Cleared
Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
58d
Cleared
Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
NHX
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
29d
Cleared
Oct 20, 2011
QUANTA FLASH (TM) DGP SCREEN
MST
Antibodies, Gliadin
153d
Cleared
Oct 13, 2011
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
294d
Cleared
Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
DHR
System, Test, Rheumatoid Factor
379d
Cleared
Sep 01, 2011
ROMA (HE4 EIA + ARCHITECT CA 125 II)
ONX
Ovarian Adnexal Mass Assessment Score Test System
289d
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