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
201–225 of 911
Cleared Jan 08, 2004
ARIOL HER-2/NEU IHC
K031715 · Applied Imaging Corp.
NOT · 220d
Cleared Dec 23, 2003
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
K032113 · Chroma Vision Medical Systems, Inc.
NOT · 167d
Cleared Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
K033612 · Roche Diagnostics Corp.
NPR · Test, Factor Ii G20210a Mutations, Genomic Dna Pcr · 31d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · Roche Diagnostics Corp.
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 9d
Cleared Jun 18, 2003
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
K023335 · Qc Sciences, LLC
NJW · Control Material, Her-2/neu, Immunohistochemistry · 254d
Cleared Dec 02, 2002
SST SALIVA SUPPORTING TABLETS
K023046 · Sinclair Pharmaceuticals, Ltd.
LED · Stains, Chemical Solution · 81d
Cleared Oct 21, 2002
IQ 200 SYSTEM
K022774 · Intl. Remote Imaging Systems
LKM · Counter, Urine Particle · 61d
Cleared Sep 30, 2002
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
K012138 · Chroma Vision Medical Systems, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 447d
Cleared Mar 08, 2002
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960 · Biogenex Laboratories
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 185d
Cleared Feb 28, 2002
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
K013148 · Biogenex Laboratories
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 161d
Cleared Feb 28, 2002
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023 · Dako Corp.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 56d
Cleared Sep 28, 2001
SYSMEX UF-50
K012372 · Sysmex Corp.
LKM · Counter, Urine Particle · 64d
Cleared Sep 14, 2001
BANDVIEW SYSTEM
K012103 · Applied Spectral Imaging , Ltd.
LNJ · Analyzer, Chromosome, Automated · 71d
Cleared Apr 13, 2001
ANEUVYSION MULITICOLOR DNA PROBE KIT
K010288 · Vysis
OYU · Dna-probe Kit, Human Chromosome · 72d
Cleared May 18, 2000
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
K001098 · Pro. Duct Health, Inc.
FMI · Needle, Hypodermic, Single Lumen · 44d
Cleared Apr 14, 2000
939UDX URINE PATHOLOGY SYSTEM
K000373 · Intl. Remote Imaging Systems
LKM · Counter, Urine Particle · 70d
Cleared Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · Dako Corp.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 102d
Cleared Feb 23, 2000
IMMUNOCYT
K994356 · Diagnocure, Inc.
NBK · System, Test, (ihc), Tumor Marker, Monitoring, Bladder Cancer · 62d
Cleared Aug 12, 1999
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · Ventana, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 232d
Cleared Jul 23, 1999
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · Ventana Medical Systems, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 148d
Cleared Oct 24, 1997
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
K972867 · Rocket Medical Plc
ICX · Aniline · 81d
Cleared Oct 20, 1997
ANEUVYSION
K972200 · Vysis
OYU · Dna-probe Kit, Human Chromosome · 132d
Cleared Jul 22, 1997
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
K972404 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KJA · Flask, Tissue Culture · 26d
Cleared Jan 21, 1997
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
K954214 · Vysis
OXP · Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment · 502d
Cleared Jan 13, 1997
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K962873 · Vysis
OVQ · Chronic Lymphocytic Leukemia Fish Probe Kit · 174d

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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