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.

3794
Total
3781
Cleared
233d
Avg (2y)
1976
Since
3794 Immunology devices
1901–1925 of 3794
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
K940588 · Helix Diagnostics, Inc.
LKO · Anti-rnp Antibody, Antigen And Control · 71d
Cleared Mar 30, 1994
VENTANA NEGATIVE CONTROL REAGENT
K931979 · Ventana Medical Systems, Inc.
DEM · Alpha-1-antitrypsin, Antigen, Antiserum, Control · 342d
Cleared Mar 25, 1994
SYNELISA ANA TOTAL
K935468 · Elias U.S.A., Inc.
LJM · Antinuclear Antibody (enzyme-labeled), Antigen, Controls · 133d
Cleared Mar 25, 1994
ELIAS ANA TOTAL
K940641 · Elias U.S.A., Inc.
LJM · Antinuclear Antibody (enzyme-labeled), Antigen, Controls · 39d
Cleared Mar 22, 1994
N-ASSAY TIA IGM
K933970 · Crestat Diagnostics, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGA
K933971 · Crestat Diagnostics, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGG
K933972 · Crestat Diagnostics, Inc.
CFF · Immunoelectrophoretic, Immunoglobulins, (g, A, M) · 221d
Cleared Mar 22, 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp.
DHB · System, Test, Radioallergosorbent (rast) Immunological · 127d
Cleared Mar 11, 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · Bio-Rad Laboratories, Inc.
DHB · System, Test, Radioallergosorbent (rast) Immunological · 92d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K926420 · Mast Immunosystems
DHB · System, Test, Radioallergosorbent (rast) Immunological · 439d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K934524 · Mast Immunosystems
DHB · System, Test, Radioallergosorbent (rast) Immunological · 168d
Cleared Jan 31, 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · Immuno Concepts, Inc.
LLL · Extractable Antinuclear Antibody, Antigen And Control · 95d
Cleared Jan 28, 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · Theratest Laboratories, Inc.
DHR · System, Test, Rheumatoid Factor · 182d
Cleared Jan 28, 1994
N-ASSAY TIA MULTI V-NL
K933973 · Crestat Diagnostics, Inc.
CFN · Method, Nephelometric, Immunoglobulins (g, A, M) · 168d
Cleared Jan 28, 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528 · E.I. Dupont DE Nemours & Co., Inc.
DBF · Ferritin, Antigen, Antiserum, Control · 73d
Cleared Jan 24, 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · Elias U.S.A., Inc.
MID · System, Test, Anticardiolipin Immunological · 82d
Cleared Jan 13, 1994
ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
K930796 · Alko Diagnostic Corp.
JZX · Equipment, Rocket Immunoelectrophoresis · 331d
Cleared Jan 11, 1994
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
K933078 · Beckman Instruments, Inc.
MGA · Alpha-1 Microglobulin, Antigen, Antiserum, Control · 202d
Cleared Jan 11, 1994
SPQ PAL CONTROL LEVEL II
K934966 · Incstar Corp.
DDS · Prealbumin, Fitc, Antigen, Antiserum, Control · 88d
Cleared Jan 11, 1994
SPQ CRP CONTROL LEVEL II
K935075 · Incstar Corp.
DCN · System, Test, C-reactive Protein · 78d
Cleared Dec 27, 1993
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc.
KTN · System, Test, Infectious Mononucleosis · 314d
Cleared Dec 21, 1993
QUANTA LITE(TM) HISTONE ELISA
K934053 · Inova Diagnostics, Inc.
LLL · Extractable Antinuclear Antibody, Antigen And Control · 124d
Cleared Dec 15, 1993
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
K933267 · Zeus Scientific, Inc.
LJM · Antinuclear Antibody (enzyme-labeled), Antigen, Controls · 162d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392 · Elias U.S.A., Inc.
MID · System, Test, Anticardiolipin Immunological · 149d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393 · Elias U.S.A., Inc.
MID · System, Test, Anticardiolipin Immunological · 149d

Looking for a specific immunology device? Search by device name, K-number or manufacturer.

Search all Immunology 510(k) devices

Filter by Product Code

All categories 3794 DHB System, Test, Radioallergosorbent (rast) Immunological 256 LLL Extractable Antinuclear Antibody, Antigen And Control 181 DHR System, Test, Rheumatoid Factor 135 LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls 112 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 106 DGC Ige, Antigen, Antiserum, Control 97 DCK C-reactive Protein, Antigen, Antiserum, And Control 96 MID System, Test, Anticardiolipin Immunological 94 JZO System, Test, Thyroid Autoantibody 89 JJY Multi-analyte Controls, All Kinds (assayed) 88 DBF Ferritin, Antigen, Antiserum, Control 76 MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca) 75 DEW Igg, Antigen, Antiserum, Control 71 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 60 KTN System, Test, Infectious Mononucleosis 57