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
Cleared
Dec 10, 2021
CINtec Histology
PRB
Cervical Intraepithelial Neoplasia (cin) Test System
151d
Not Cleared
Sep 21, 2021
Paige Prostate
QPN
Software Algorithm Device To Assist Users In Digital Pathology
264d
Cleared
Sep 17, 2021
Philips IntelliSite Pathology Solution
PSY
Whole Slide Imaging System
260d
Cleared
Jul 26, 2021
OncoMate MSI Dx Analysis System
PZJ
Lynch Syndrome Test System
552d
Cleared
Jul 14, 2021
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
PZM
Next Generation Sequencing Based Tumor Profiling Test
334d
Cleared
Apr 15, 2021
MDPC-8127
PSY
Whole Slide Imaging System
150d
Cleared
Nov 05, 2020
MammaPrint
NYI
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
120d
Cleared
Jul 15, 2020
FullFocus
QKQ
Digital Pathology Image Viewing And Management Software
90d
Cleared
Apr 24, 2020
PGDx elio tissue complete
PZM
Next Generation Sequencing Based Tumor Profiling Test
267d
Cleared
Mar 31, 2020
Sectra Digital Pathology Module
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).
MXZ
Immunohistochemistry Assay, Antibody, Progesterone Receptor
91d
Cleared
Nov 09, 2019
Omics Core
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
OYX
Bcr/abl1 Monitoring Test
254d
Cleared
Sep 20, 2019
Philips IntelliSite Pathology Solution
PSY
Whole Slide Imaging System
30d
Cleared
May 20, 2019
Aperio AT2 DX System
PSY
Whole Slide Imaging System
95d
Cleared
Apr 25, 2019
exCellerator Cervical Collection Device
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
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
MXZ
Immunohistochemistry Assay, Antibody, Progesterone Receptor
30d
Not Cleared
Sep 28, 2018
Adaptive Biotechnologies clonoSEQ Assay
QDC
Dna-based Test For Minimal Residual Disease For Hematologic Malignancies
364d
Cleared
Mar 15, 2018
Tissue of Origin Test Kit-FFPE
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)
QAZ
Cancer Predisposition Risk Assessment System
182d
Cleared
Jan 12, 2018
ipsogen JAK2 RGQ PCR Kit
PSU
Jak2 Gene Mutation Detection Test
168d
Cleared
Dec 22, 2017
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
OYX
Bcr/abl1 Monitoring Test
39d
Cleared
Dec 21, 2017
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
MXZ
Immunohistochemistry Assay, Antibody, Progesterone Receptor
352d
Cleared
Dec 21, 2017
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
MYA
Immunohistochemistry Antibody Assay, Estrogen Receptor
352d
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