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
301–325 of 774
Cleared May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · Roche Diagnostics Corp.
DDG · Transferrin, Antigen, Antiserum, Control · 211d
Cleared Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · bioMerieux, Inc.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 57d
Cleared Apr 11, 2001
VIGIL DNASE B CONTROL
K010693 · Beckman Coulter, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 34d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · Beckman Coulter, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 70d
Cleared Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
K010588 · Roche Diagnostics Corp.
MOI · System, Test, Immunological, Antigen, Tumor · 29d
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · Baxter Healthcare Corp
DBA · Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control · 105d
Cleared Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · Helena Laboratories
DEW · Igg, Antigen, Antiserum, Control · 14d
Cleared Mar 05, 2001
VIGIL SEROLOGY CONTROL LEVEL C
K010358 · Beckman Coulter, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 27d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · Dade Behring, Inc.
LTJ · Prostate-specific Antigen (psa) For Management Of Prostate Cancers · 68d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · Dade Behring, Inc.
DCN · System, Test, C-reactive Protein · 104d
Cleared Jan 12, 2001
CA 125 II CALCHECK
K003967 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 21d
Cleared Jan 12, 2001
ELECSYS CA 125 II CALSET
K003969 · Roche Diagnostics Corp.
JIS · Calibrator, Primary · 21d
Cleared Dec 26, 2000
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · Diagnostic Products Corp.
DCN · System, Test, C-reactive Protein · 57d
Cleared Nov 20, 2000
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc.
JZG · System, Test, Beta-2-microglobulin Immunological · 80d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468 · Roche Diagnostics Corp.
MOI · System, Test, Immunological, Antigen, Tumor · 166d
Cleared Oct 19, 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc.
MSW · System, Test, Thyroglobulin · 31d
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · Dade Behring, Inc.
JZW · Nephelometer · 119d
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · Roche Diagnostics Corp.
DHR · System, Test, Rheumatoid Factor · 14d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353 · Roche Diagnostics Corp.
JIS · Calibrator, Primary · 8d
Cleared Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
K001014 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 64d
Cleared May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · Roche Diagnostics Corp.
JZO · System, Test, Thyroid Autoantibody · 119d
Cleared Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · Roche Diagnostics Corp.
DHR · System, Test, Rheumatoid Factor · 48d
Cleared Apr 05, 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781 · Bio-Rad
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 230d
Cleared Mar 01, 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 71d

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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 JJX Single (specified) Analyte Controls (assayed And Unassayed) 19 DGC Ige, Antigen, Antiserum, Control 19 CFN Method, Nephelometric, Immunoglobulins (g, A, M) 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