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
151–175 of 911
Cleared Feb 04, 2009
MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
K082150 · Preanalytix GmbH
NTW · System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test · 189d
Cleared Feb 03, 2009
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
K083002 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 118d
Cleared Dec 16, 2008
INTROL CF PANEL I CONTROL, MODEL: G106
K083171 · Maine Molecular Quality Controls, Inc.
NZB · Quality Control Material, Genetics, Dna · 50d
Cleared Oct 31, 2008
SCANSCOPE XT SYSTEM
K080254 · Aperio Technologies
OEO · Automated Digital Image Manual Interpretation Microscope · 274d
Cleared Oct 17, 2008
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K080909 · Ikonisys, Inc.
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 199d
Cleared Aug 01, 2008
SCANSCOPE XT SYSTEM
K073677 · Aperio Technologies
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 217d
Cleared Jul 30, 2008
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
K080896 · Pathwork Diagnostics, Inc.
OIW · Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types · 121d
Cleared Jul 21, 2008
MODIFICATION TO MAMMAPRINT
K080252 · Agendia BV
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 172d
Cleared May 02, 2008
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 32d
Cleared Mar 13, 2008
INPLEX CF MOLECULAR TEST
K063787 · Third Wave Technologies, Inc.
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 448d
Cleared Feb 26, 2008
CELLSEARCH CIRCULATING TUMOR CELL KIT
K073338 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 90d
Cleared Dec 28, 2007
SCANSCOPE XT SYSTEM
K071671 · Aperio Technologies
OEO · Automated Digital Image Manual Interpretation Microscope · 192d
Cleared Nov 20, 2007
CELLSEARCH CIRCULATING TUMOR CELL KIT
K071729 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 148d
Cleared Oct 10, 2007
SCANSCOPE XT SYSTEM
K071128 · Aperio Technologies
NOT · 170d
Cleared Sep 07, 2007
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
K062028 · Celera Diagnostics
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 416d
Cleared Jun 22, 2007
MAMMAPRINT
K070675 · Agendia BV
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 102d
Cleared May 25, 2007
SYSMEX MODEL UF1000I
K070910 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 53d
Cleared Feb 20, 2007
PATHIAM IMAGING SOFTWARE FOR HER2/NEU
K062756 · Bioimagene, Inc.
NOT · 159d
Cleared Feb 07, 2007
INFINITI SYSTEM
K060564 · AutoGenomics, Inc.
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 341d
Not Cleared Feb 06, 2007
MAMMAPRINT
DEN070009 · Agendia BV
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 7d
Cleared Jan 29, 2007
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
K062615 · Vision Biosystems, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 146d
Cleared Jan 10, 2007
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
K061613 · Tripath Imaging
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 215d
Cleared Dec 14, 2006
CELLSEARCH CIRCULATING TUMOR CELL KIT
K062013 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 150d
Not Cleared Oct 12, 2006
INTROL CF PANEL I CONTROL
DEN060007 · Maine Molecular Quality Controls, Inc.
NZB · Quality Control Material, Genetics, Dna · 59d
Cleared Sep 29, 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
K062428 · Tripath Imaging, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 42d

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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