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
76–100 of 639
Cleared Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · Ventana Medical Systems, Inc.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 719d
Cleared Jun 01, 2012
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · Ventana Medical Systems, Inc.
NOT · 28d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 293d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc.
NQN · Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity · 248d
Cleared Feb 22, 2012
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755 · Ventana Medical Systems, Inc.
NOT · 245d
Cleared Oct 12, 2011
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · Ventana Medical Systems, Inc.
NOT · 132d
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 May 04, 2010
HEMOSIL F11 & FV DNA CONTROL
K093737 · Instrumentation Laboratory CO
NZB · Quality Control Material, Genetics, Dna · 151d
Cleared Sep 18, 2009
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
K082118 · Cepheid
NPQ · Test, Factor V Leiden Mutations, Genomic Dna Pcr · 417d
Cleared Feb 03, 2009
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
K083002 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 118d
Cleared May 02, 2008
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 32d
Cleared May 25, 2007
SYSMEX MODEL UF1000I
K070910 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 53d
Cleared Jan 04, 2006
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
K053135 · Sysmex America, Inc.
LKM · Counter, Urine Particle · 57d
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 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 Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · Dako Corp.
MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor · 102d
Cleared Jul 23, 1999
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · Ventana Medical Systems, Inc.
MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor · 148d
Cleared Jul 22, 1997
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
K972404 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KJA · Flask, Tissue Culture · 26d
Cleared May 30, 1995
SALINE SOLUTINE, STERILE
K950560 · Busse Hospital Disposables, Inc.
IGE · Solution, Formalin Ammonium Bromide · 111d
Cleared Aug 26, 1994
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
K936271 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 239d
Cleared Jun 16, 1994
FRESH FROZEN CELLS
K940502 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 134d

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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 IAF Wright's Stain 7 PZM Next Generation Sequencing Based Tumor Profiling Test 7 HZJ Stain, Papanicolau 7 KIP Formulations, Balanced Salt Solutions 7 KEO Formulations, Paraffin, All 7 IEO Processor, Tissue, Automated 6 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 6