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.
1101
Total
1078
Cleared
212d
Avg (2y)
1976
Since
163 Pathology devices
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 21, 2017
MMPC-4127F1
PZZ
Digital Pathology Display
87d
Cleared
Oct 04, 2017
Philips IntelliSite Pathology Solution
PSY
Whole Slide Imaging System
77d
Not Cleared
Apr 12, 2017
Philips IntelliSite Pathology Solution
PSY
Whole Slide Imaging System
132d
Not Cleared
Mar 04, 2017
CINtec Histology (50 tests), CINtec Histology (250 tests)
PRB
Cervical Intraepithelial Neoplasia (cin) Test System
285d
Cleared
Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
OEO
Automated Digital Image Manual Interpretation Microscope
275d
Cleared
May 04, 2010
HEMOSIL F11 & FV DNA CONTROL
NZB
Quality Control Material, Genetics, Dna
151d
Cleared
Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
NPR
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
31d
Not Cleared
Dec 17, 2003
FACTOR V LEIDEN KIT
NPQ
Test, Factor V Leiden Mutations, Genomic Dna Pcr
9d
Cleared
Jul 22, 1997
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
KJA
Flask, Tissue Culture
26d
Cleared
Dec 18, 1990
NITRO BLUE TETRAZOLIUM REDUCTION
GHD
Test, Leukocyte Alkaline Phosphatase
110d
Cleared
Dec 13, 1990
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
GHD
Test, Leukocyte Alkaline Phosphatase
106d
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