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.

3792
Total
3779
Cleared
232d
Avg (2y)
1976
Since
3128 Immunology devices
1726–1750 of 3128
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 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
Cleared Dec 03, 1993
SYNELISA ANA PROFILE
K932206 · Elias U.S.A., Inc.
LJM · Antinuclear Antibody (enzyme-labeled), Antigen, Controls · 211d
Cleared Nov 15, 1993
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · Shield Diagnostics, Ltd.
LKJ · Antinuclear Antibody, Antigen, Control · 154d
Cleared Nov 03, 1993
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589 · Boehringer Mannheim Corp.
DDG · Transferrin, Antigen, Antiserum, Control · 100d

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 3128 DHB System, Test, Radioallergosorbent (rast) Immunological 219 LLL Extractable Antinuclear Antibody, Antigen And Control 147 DHR System, Test, Rheumatoid Factor 105 JJY Multi-analyte Controls, All Kinds (assayed) 82 LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls 80 DCK C-reactive Protein, Antigen, Antiserum, And Control 78 MID System, Test, Anticardiolipin Immunological 77 DGC Ige, Antigen, Antiserum, Control 75 JZO System, Test, Thyroid Autoantibody 72 DBF Ferritin, Antigen, Antiserum, Control 68 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 68 MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca) 66 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 56 DEW Igg, Antigen, Antiserum, Control 54 JJX Single (specified) Analyte Controls (assayed And Unassayed) 50