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.

1105
Total
1082
Cleared
212d
Avg (2y)
1976
Since
639 Pathology devices
51–75 of 639
Cleared Apr 24, 2020
PGDx elio tissue complete
K192063 · Personal Genome Diagnostics
PZM · Next Generation Sequencing Based Tumor Profiling Test · 267d
Cleared Mar 31, 2020
Sectra Digital Pathology Module
K193054 · Sectra AB
QKQ · Digital Pathology Image Viewing And Management Software · 151d
Cleared Mar 06, 2020
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
K193393 · Leica Biosystems Newcastle, Ltd.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 91d
Cleared Nov 09, 2019
Omics Core
K190661 · Nanthealth, Inc.
PZM · Next Generation Sequencing Based Tumor Profiling Test · 240d
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
K190076 · Cepheid
OYX · Bcr/abl1 Monitoring Test · 254d
Cleared Sep 20, 2019
Philips IntelliSite Pathology Solution
K192259 · Philips Electronics Nederland B.V.
PSY · Whole Slide Imaging System · 30d
Cleared May 20, 2019
Aperio AT2 DX System
K190332 · Leica Biosystems Imaging, Inc.
PSY · Whole Slide Imaging System · 95d
Cleared Apr 25, 2019
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC
HHT · Spatula, Cervical, Cytological · 268d
Cleared Dec 07, 2018
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
K183100 · Leica Biosystems Newcastle, Limited
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 30d
Cleared Dec 07, 2018
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K183102 · Leica Biosystems Newcastle, Limited
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 30d
Not Cleared Sep 28, 2018
Adaptive Biotechnologies clonoSEQ Assay
DEN170080 · Adaptive Biotechnologies Corporation
QDC · Dna-based Test For Minimal Residual Disease For Hematologic Malignancies · 364d
Cleared Mar 15, 2018
Tissue of Origin Test Kit-FFPE
K173839 · Cancer Genetics, Inc.
OIW · Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types · 87d
Not Cleared Mar 06, 2018
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
DEN170046 · 23AndMe, Inc.
QAZ · Cancer Predisposition Risk Assessment System · 182d
Cleared Jan 12, 2018
ipsogen JAK2 RGQ PCR Kit
K172287 · Qiagen, Inc.
PSU · Jak2 Gene Mutation Detection Test · 168d
Cleared Dec 21, 2017
MMPC-4127F1
K172922 · Barco N.V.
PZZ · Digital Pathology Display · 87d
Cleared Oct 04, 2017
Philips IntelliSite Pathology Solution
K172174 · Philips Medical Systems Nederland B.V.
PSY · Whole Slide Imaging System · 77d
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 04, 2017
CINtec Histology (50 tests), CINtec Histology (250 tests)
DEN160019 · Ventana Medical Systems, Inc.
PRB · Cervical Intraepithelial Neoplasia (cin) Test System · 285d
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 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
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
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 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · Ventana Medical Systems, Inc.
NOT · 519d

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All categories 639 KIT Media And Components, Synthetic Cell And Tissue Culture 212 KIR Cells, Animal And Human, Cultured 65 KIS Sera, Animal And Human 20 PSY Whole Slide Imaging System 19 JTS Stains, Microbiologic 16 QKQ Digital Pathology Image Viewing And Management Software 13 HYJ Hematoxylin 8 IFP Formalin, Neutral Buffered 8 PZM Next Generation Sequencing Based Tumor Profiling Test 7 HZJ Stain, Papanicolau 7 KIP Formulations, Balanced Salt Solutions 7 KEO Formulations, Paraffin, All 7 IAF Wright's Stain 7 IEO Processor, Tissue, Automated 6 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 6