FDA Review Panel · PA

FDA 510(k) Pathology Devices

FDA 510(k) Pathology Devices - Regulatory Overview

FDA 510(k) pathology devices include instruments used in anatomical and clinical pathology laboratories. The FDA review panel code is PA.

Key categories:

  • Tissue staining systems - automated H&E, IHC and special stain platforms
  • Histology instruments - microtomes, tissue processors and embedding stations
  • Digital pathology - whole slide imaging (WSI) scanners and image analysis software
  • Cytology systems - liquid-based cytology and automated cell screening

Most pathology devices are Class I or Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.

1109
Total
1086
Cleared
214d
Avg (2y)
1976
Since
911 Pathology devices
101–125 of 911
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
K124006 · Illumina, Inc.
PFR · System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection · 328d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
K132750 · Illumina, Inc.
PFS · System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection · 77d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 492d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 427d
Cleared Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
K130021 · Philips Medical Systems Nederland B.V.
OEO · Automated Digital Image Manual Interpretation Microscope · 259d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · Abbott Molecular, Inc.
PFG · Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders · 112d
Cleared Sep 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · Ventana Medical Systems, Inc.
NOT · 519d
Cleared Sep 06, 2013
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K130010 · Nanostring Technologies
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 246d
Not Cleared Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
DEN130010 · Abbott Molecular, Inc.
PDO · Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization · 111d
Cleared Jun 20, 2013
CELLTRACKS ANALYZER II SYSTEM
K130794 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 90d
Cleared Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · Dako North America, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 344d
Cleared Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554 · Applied Spectral Imaging , Ltd.
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 170d
Cleared Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · Ventana Medical Systems, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 719d
Cleared Dec 13, 2012
CELLTRACKS AUTOPREP SYSTEM
K122821 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 90d
Cleared Aug 21, 2012
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
K111914 · Olympus America Inc. / Scientific Equipment Group
OEO · Automated Digital Image Manual Interpretation Microscope · 412d
Cleared Jun 01, 2012
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · Ventana Medical Systems, Inc.
NOT · 28d
Cleared May 17, 2012
TISSUE OF ORIGIN TEST KIT FFPE
K120489 · Pathwork Diagnostics, Inc.
OIW · Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types · 90d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 293d
Cleared Mar 16, 2012
RNARETAIN
K113420 · Asuragen, Inc.
OZF · Tissue Rna Preservative For Collection, Storage, And Transportation · 119d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 248d
Cleared Feb 22, 2012
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755 · Ventana Medical Systems, Inc.
NOT · 245d
Cleared Jan 20, 2012
CELLTRACKS AUTOPREP SYSTEM
K110406 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 340d
Cleared Dec 12, 2011
CELLTRACKS ANALYER II
K113181 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 45d
Cleared Nov 16, 2011
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
K103818 · Ventana Medical Sytems, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 322d
Cleared Oct 19, 2011
SCANVIEW SYSTEM
K110345 · Applied Spectral Imaging
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 257d

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All categories 911 KIT Media And Components, Synthetic Cell And Tissue Culture 228 KIR Cells, Animal And Human, Cultured 123 JTS Stains, Microbiologic 26 PSY Whole Slide Imaging System 23 KIS Sera, Animal And Human 20 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 15 QKQ Digital Pathology Image Viewing And Management Software 14 NOT 13 NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration 13 MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor 13 IAF Wright's Stain 12 MYA Immunohistochemistry Antibody Assay, Estrogen Receptor 12 IEO Processor, Tissue, Automated 11 NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection 10 NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer 10