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
76–100 of 911
Cleared Dec 21, 2017
MMPC-4127F1
K172922 · Barco N.V.
PZZ · Digital Pathology Display · 87d
Not Cleared Nov 15, 2017
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
DEN170058 · Memorial Sloan-Kettering Cancer Center
PZM · Next Generation Sequencing Based Tumor Profiling Test · 51d
Not Cleared Oct 27, 2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
DEN170030 · Ventana Medical Systems
PZJ · Lynch Syndrome Test System · 150d
Cleared Oct 04, 2017
Philips IntelliSite Pathology Solution
K172174 · Philips Medical Systems Nederland B.V.
PSY · Whole Slide Imaging System · 77d
Cleared Jul 21, 2017
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
K171753 · Leica Biosystems Newcastle, Limited
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 39d
Not Cleared Apr 12, 2017
Philips IntelliSite Pathology Solution
DEN160056 · Philips Medical Systems Nederland B.V.
PSY · Whole Slide Imaging System · 132d
Not Cleared Mar 27, 2017
ipsogen JAK2 RGQ PCR Kit
DEN160028 · Qiagen, Inc.
PSU · Jak2 Gene Mutation Detection Test · 269d
Not Cleared Mar 04, 2017
CINtec Histology (50 tests), CINtec Histology (250 tests)
DEN160019 · Ventana Medical Systems, Inc.
PRB · Cervical Intraepithelial Neoplasia (cin) Test System · 285d
Cleared Jan 13, 2017
Kolplast Cervical Sample Collection Kit
K153128 · Kolplast CI SA
HHT · Spatula, Cervical, Cytological · 442d
Cleared May 03, 2016
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)
K160922 · Dako North America, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 29d
Cleared Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
K142965 · Ventana Medical Systems, Inc.
OEO · Automated Digital Image Manual Interpretation Microscope · 275d
Cleared Jan 23, 2015
MAMMAPRINT FFPE
K141142 · Agendia
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 266d
Cleared Jan 15, 2015
GENASIS HIPATH IHC FAMILY
K140957 · Applied Spectral Imaging , Ltd.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 276d
Not Cleared Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010 · Wallac OY
PJI · Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System · 299d
Cleared Nov 07, 2014
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K141771 · Nanostring Technologies, Inc.
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 129d
Cleared Jul 29, 2014
APERIO EPATHOLOGY EIHC IVD SYSTEM
K141109 · Leica Biosystems Imaging, Inc.
NOT · 91d
Cleared Jun 13, 2014
IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
K132978 · Sequenom, Inc.
PHJ · System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations · 263d
Cleared May 19, 2014
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · Leica Biosystems Newcastle, Ltd.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 635d
Cleared May 09, 2014
DUET SYSTEM
K130775 · Bioview , Ltd.
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 415d
Cleared Apr 01, 2014
OMNYX IDP FOR HER2 MANUAL APPLICATION
K131140 · Omnyx, LLC
OEO · Automated Digital Image Manual Interpretation Microscope · 344d
Cleared Mar 20, 2014
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 24d
Not Cleared Jan 17, 2014
CYTOSCAN(R) DX
DEN130018 · Affymetrix, Inc.
PFX · System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection · 30d
Cleared Jan 10, 2014
FLEXMAP 3D
K133302 · Luminex Corp.
NSU · Instrumentation For Clinical Multiplex Test Systems · 77d
Cleared Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861 · Dako North America, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 256d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 268d

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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