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
126–150 of 911
Cleared Oct 12, 2011
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · Ventana Medical Systems, Inc.
NOT · 132d
Cleared Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
K091960 · Abbott Molecular, Inc.
OWK · Early Growth Response 1 (egr) Fish Probe Kit · 789d
Cleared Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
K100015 · Abbott Molecular, Inc.
OVQ · Chronic Lymphocytic Leukemia Fish Probe Kit · 582d
Cleared Jun 02, 2011
INVADER FACTOR II
K100943 · Hologic, Inc.
NPR · Test, Factor Ii G20210a Mutations, Genomic Dna Pcr · 422d
Cleared Jun 01, 2011
INVADER FACTOR V
K100980 · Hologic, Inc.
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 419d
Cleared May 13, 2011
INVADER MTHFR 677
K100987 · Hologic, Inc.
OMM · Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr · 399d
Cleared Apr 25, 2011
INVADER MTHFR 1298
K100496 · Hologic, Inc.
OMM · Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr · 427d
Cleared Jan 28, 2011
MAMMAPRINT
K101454 · Agendia
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 248d
Cleared Dec 21, 2010
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
K103502 · Veridex, LLC
NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration · 22d
Cleared Nov 23, 2010
SCANVIEW HER2/NEU FISH SYSTEM
K101291 · Applied Spectral Imaging , Ltd.
NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays · 200d
Cleared Oct 27, 2010
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
K092333 · Bioimagene, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 449d
Cleared Jun 08, 2010
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
K092967 · Pathwork Diagnostics
OIW · Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types · 256d
Cleared May 04, 2010
HEMOSIL F11 & FV DNA CONTROL
K093737 · Instrumentation Laboratory CO
NZB · Quality Control Material, Genetics, Dna · 151d
Cleared Apr 28, 2010
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
K093129 · Illumina, Inc.
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 208d
Cleared Apr 22, 2010
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
K093974 · Osmetech Molecular Diagnostics
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 120d
Cleared Feb 05, 2010
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
K093861 · Iris International, Inc.
LKM · Counter, Urine Particle · 51d
Cleared Dec 11, 2009
MODIFICATION TO MAMMAPRINT
K081092 · Agendia
NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer · 603d
Cleared Dec 11, 2009
XTAG CF60 KIT V2
K083845 · Luminex Molecular Diagnostics, Inc.
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 352d
Cleared Sep 18, 2009
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
K082118 · Cepheid
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 417d
Cleared Sep 01, 2009
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
K083846 · Luminex Molecular Diagnostics, Inc.
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 251d
Cleared Aug 14, 2009
SCANSCOPE XT SYSTEM
K080564 · Aperio Technologies
NOT · 533d
Cleared Jul 24, 2009
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
K083294 · Nanosphere, Inc.
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 256d
Cleared Jul 06, 2009
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
K090901 · Osmetech Molecular Diagnostics
NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection · 96d
Cleared May 08, 2009
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
K081286 · Dako North America, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 366d
Cleared Feb 04, 2009
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
K080910 · Bioimagene, Inc.
NOT · 309d

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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 MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor 13 NOT 13 NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration 13 MYA Immunohistochemistry Antibody Assay, Estrogen Receptor 12 IAF Wright's Stain 12 IEO Processor, Tissue, Automated 11 NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer 10 NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection 10