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.

3787
Total
3774
Cleared
236d
Avg (2y)
1976
Since
2394 Immunology devices
951–975 of 2394
Cleared Sep 04, 1997
UNICAP PHADIATOP
K972364 · Pharmacia, Inc.
DHB · System, Test, Radioallergosorbent (rast) Immunological · 71d
Cleared Aug 28, 1997
RAICHEM PREALBUMIN SPIA
K972812 · Hemagen Diagnostics, Inc.
DDS · Prealbumin, Fitc, Antigen, Antiserum, Control · 31d
Cleared Aug 22, 1997
IMMULITE 2000 PSA
K972095 · Diagnostic Products Corp.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 79d
Cleared Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · Beckman Instruments, Inc.
DDG · Transferrin, Antigen, Antiserum, Control · 84d
Cleared Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235 · Boehringer Mannheim Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 57d
Cleared Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
K972608 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 54d
Cleared Aug 01, 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K972160 · Trinity Laboratories, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 53d
Cleared Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
K964282 · Boehringer Mannheim Corp.
JMG · Radioimmunoassay (two-site Solid Phase), Ferritin · 275d
Cleared Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
K972513 · Boehringer Mannheim Corp.
DDR · Myoglobin, Antigen, Antiserum, Control · 21d
Cleared Jul 25, 1997
ELECSYS PSA ASSAY
K964351 · Boehringer Mannheim Corp.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 266d
Cleared Jul 23, 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · Zeus Scientific, Inc.
MID · System, Test, Anticardiolipin Immunological · 70d
Cleared Jul 03, 1997
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · Pharmacia, Inc.
DHB · System, Test, Radioallergosorbent (rast) Immunological · 30d
Cleared Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · Beckman Instruments, Inc.
DHR · System, Test, Rheumatoid Factor · 57d
Cleared Jun 24, 1997
OPUS PSA TEST SYSTEM
K964595 · Behring Diagnostics, Inc.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 218d
Cleared Jun 24, 1997
QUANTA LITE B2GPI IGG
K970551 · Inova Diagnostics, Inc.
MSV · System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) · 132d
Cleared Jun 20, 1997
QUANTA LITE RF IGM
K971614 · Inova Diagnostics, Inc.
DHR · System, Test, Rheumatoid Factor · 49d
Cleared Jun 20, 1997
VIRGO AMA ELISA KIT
K971909 · Hemagen Diagnostics, Inc.
DBM · Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control · 28d
Cleared Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · Boehringer Mannheim Corp.
DHR · System, Test, Rheumatoid Factor · 64d
Cleared Jun 16, 1997
ELECSYS CEA ASSAY
K964368 · Boehringer Mannheim Corp.
JIT · Calibrator, Secondary · 227d
Cleared Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · Beckman Instruments, Inc.
CZW · Complement C3, Antigen, Antiserum, Control · 190d
Cleared Jun 11, 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · Immco Diagnostics, Inc.
MID · System, Test, Anticardiolipin Immunological · 145d
Cleared Jun 03, 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · Hemagen Diagnostics, Inc.
MID · System, Test, Anticardiolipin Immunological · 74d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
K971283 · Beckman Instruments, Inc.
JIX · Calibrator, Multi-analyte Mixture · 57d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
K971788 · Beckman Instruments, Inc.
DHR · System, Test, Rheumatoid Factor · 20d
Cleared Jun 02, 1997
QUANTA LITE IGA GLIADIN ELISA
K964986 · Inova Diagnostics, Inc.
MST · Antibodies, Gliadin · 171d

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All categories 2394 DHB System, Test, Radioallergosorbent (rast) Immunological 175 LLL Extractable Antinuclear Antibody, Antigen And Control 116 DHR System, Test, Rheumatoid Factor 77 JJY Multi-analyte Controls, All Kinds (assayed) 69 DGC Ige, Antigen, Antiserum, Control 67 DCK C-reactive Protein, Antigen, Antiserum, And Control 62 DBF Ferritin, Antigen, Antiserum, Control 56 DEW Igg, Antigen, Antiserum, Control 51 DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 51 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 51 MID System, Test, Anticardiolipin Immunological 46 JJX Single (specified) Analyte Controls (assayed And Unassayed) 44 DEH Lambda, Antigen, Antiserum, Control 42 DFH Kappa, Antigen, Antiserum, Control 39 JZO System, Test, Thyroid Autoantibody 39