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
176–200 of 911
Cleared Jun 27, 2006
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
K061360 · Lab Vision Corp.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 42d
Cleared Jun 07, 2006
TAG-IT CYSTIC FIBROSIS KIT
K060627 · Tm Bioscience Corporation
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 90d
Cleared May 25, 2006
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K060227 · Vision Biosystems, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 115d
Cleared Apr 24, 2006
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
K060462 · Lab Vision Corp.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 61d
Cleared Apr 11, 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
K053520 · Tripath Imaging, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 113d
Cleared Mar 28, 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
K060543 · Clinical Micro Sensors, Inc.
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 27d
Cleared Mar 16, 2006
CELLTRACKS ANALYZER II
K060110 · Immunicon Corp.
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 58d
Cleared Jan 19, 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
K051435 · Clinical Micro Sensors
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 232d
Cleared Jan 04, 2006
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
K053135 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 57d
Cleared Oct 27, 2005
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
K052191 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 77d
Cleared Aug 16, 2005
VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU
K051282 · Tripath Imaging, Inc.
NOT · 91d
Cleared Aug 08, 2005
SLIVASURE
K051409 · Scandinavian Formulas, Inc.
LED · Stains, Chemical Solution · 69d
Cleared Jun 27, 2005
FISHVIEW
K050236 · Applied Spectral Imaging , Ltd.
LNJ · Analyzer, Chromosome, Automated · 147d
Not Cleared May 09, 2005
TAG-IT CYSTIC FIBROSIS KIT
DEN050004 · Tm Bioscience Corporation
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 34d
Cleared May 06, 2005
VENTANA IMAGE ANALYSIS SYSTEM
K050012 · Tripath Imaging, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 123d
Cleared Apr 25, 2005
ARIOL HER-2/NEU FISH
K043519 · Applied Imaging Corp.
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 126d
Not Cleared Apr 18, 2005
PAXGENE BLOOD RNA SYSTEM
DEN050003 · Preanalytix GmbH
NTW · System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test · 49d
Cleared Mar 15, 2005
CELLTRACKA ANALYZER II
K050145 · Immunicon Corp.
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 50d
Cleared Mar 15, 2005
CELLSEARCH CIRCULATING TUMOR CELL KIT
K050245 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 41d
Cleared Feb 15, 2005
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884 · Dakocytomation California, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 119d
Cleared Feb 09, 2005
PROSTATE-63 CANCER DIAGNOSTIC TEST
K050063 · Asymmetrx
NTR · Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells · 29d
Not Cleared Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
DEN040010 · Vysis
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 61d
Cleared Mar 18, 2004
ARIOL
K033200 · Applied Imaging Corp.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 168d
Cleared Feb 05, 2004
QCA (VERSION 3.1)
K031363 · Cell Analysis, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 281d
Not Cleared Jan 21, 2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT
DEN040001 · Advanced Diagnostic Systems
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 19d

Looking for a specific pathology device? Search by device name, K-number or manufacturer.

Search all Pathology 510(k) devices

Filter by Product Code

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 NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration 13 MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor 13 NOT 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