Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP100027
Supplement NumberS002
Date Received09/19/2011
Decision Date02/15/2012
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MIGRATION OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY TO THE BENCHMARK ULTRA AUTO-STAINER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY AND IS INDICATED FOR USE INDETERMINING HER2 GENE STATUS BY ENUMERATION OF THE RATIO OF THE HER2 GENE TO CHROMOSOME 17. THE HER2 AND CHROMOSOME 17 PROBES ARE DETECTED USING TWO COLOR CHROMOGENIC IN SITU HYBRIDIZATION (ISH) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS FOLLOWING STAINING ON VENTANA BENCHMARK XT AUTOMATED SLIDE STAINERS (USING NEXES SOFTWARE), OR ON VENTANA BENCHMARK ULTRA AUTOMATED SLIDE STAINER (USING VSS SOFTWARE), BY LIGHTMICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION, RELEVANT CLINICAL INFORMATION, AND PROPER CONTROLS. THIS REAGENT IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE.
-
-