FDA Review Panel · IM

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
176–200 of 774
Cleared Sep 05, 2017
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
K163525 · Inova Diagnostics, Inc.
DBM · Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control · 264d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642 · Siemens Healthcare Diagnostics, Inc.
DBF · Ferritin, Antigen, Antiserum, Control · 90d
Cleared Jul 03, 2017
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
K170974 · Becton, Dickinson and Company
OYE · Flow Cytometric Reagents And Accessories. · 91d
Cleared Feb 03, 2017
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · Inova Diagnostics, Inc.
MOB · Test System, Antineutrophil Cytoplasmic Antibodies (anca) · 275d
Cleared Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 162d
Cleared Jan 09, 2017
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
K162208 · Beckman Coulter, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 157d
Cleared Apr 10, 2015
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
K141932 · Beckman Coulter, Inc.
OYE · Flow Cytometric Reagents And Accessories. · 268d
Cleared Jan 07, 2014
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
K130122 · Beckman Coulter, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 355d
Cleared Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · Helena Laboratories
JJY · Multi-analyte Controls, All Kinds (assayed) · 138d
Cleared Jul 15, 2013
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
K130253 · Beckman Coulter, Inc.
PER · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis · 164d
Cleared Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc.
JNL · Immunochemical, Thyroglobulin Autoantibody · 85d
Cleared Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603 · Beckman Coulter, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 58d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 141d
Cleared May 21, 2010
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO
MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 359d
Cleared Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · Instrumentation Laboratory CO
MID · System, Test, Anticardiolipin Immunological · 233d
Cleared Dec 11, 2009
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc.
DBF · Ferritin, Antigen, Antiserum, Control · 119d
Cleared Jun 22, 2009
VIDAS CA 15-3 ASSAY
K080469 · bioMerieux, Inc.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 487d
Cleared Apr 10, 2009
VIDAS CA 125 II ASSAY
K080561 · bioMerieux, Inc.
LTK · Test, Epithelial Ovarian Tumor-associated Antigen (ca125) · 407d
Cleared Mar 18, 2009
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp.
DCN · System, Test, C-reactive Protein · 117d
Cleared Oct 09, 2008
VIDAS CEA (S) ASSAY
K080194 · bioMerieux, Inc.
DHX · System, Test, Carcinoembryonic Antigen · 258d
Cleared Sep 26, 2008
VIDAS AFP ASSAY
K080017 · bioMerieux, Inc.
LOJ · Kit, Test,alpha-fetoprotein For Testicular Cancer · 267d
Cleared Aug 11, 2008
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
K080634 · Beckman Coulter, Inc.
DDG · Transferrin, Antigen, Antiserum, Control · 158d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · Roche Diagnostics Corp.
JZO · System, Test, Thyroid Autoantibody · 196d
Cleared Jul 28, 2008
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
K081161 · Dade Behring, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 95d
Cleared Jul 21, 2008
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
K081249 · Dade Behring, Inc.
DEB · Alpha-2-macroglobulin, Antigen, Antiserum, Control · 80d

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All categories 774 DHB System, Test, Radioallergosorbent (rast) Immunological 56 JJY Multi-analyte Controls, All Kinds (assayed) 33 DCK C-reactive Protein, Antigen, Antiserum, And Control 26 DHR System, Test, Rheumatoid Factor 24 DDG Transferrin, Antigen, Antiserum, Control 21 DBF Ferritin, Antigen, Antiserum, Control 21 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 19 JJX Single (specified) Analyte Controls (assayed And Unassayed) 19 DGC Ige, Antigen, Antiserum, Control 19 DFH Kappa, Antigen, Antiserum, Control 18 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 18 DEW Igg, Antigen, Antiserum, Control 17 CZP Iga, Antigen, Antiserum, Control 16 DCN System, Test, C-reactive Protein 16 JZO System, Test, Thyroid Autoantibody 15