PMA P040005S006

Device: HER2 FISH PHARMADX KIT
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P040005
Supplement: S006
Product code: MVD
Decision date: 2012-06-08
Classification: System, Test, Her-2/neu, Nucleic Acid Or Serum
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Approval order statement: APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 FISH PHARMDX KIT AND ITS INDICATION FOR USE IS: A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TOQUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST AND GASTRIC CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED AND FOR BREAST CANCER PATIENTS FOR WHOM PERJETA (PERTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).

Current openFDA PMA Record#

Device: HER2 FISH PHARMADX KIT
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P040005
Supplement: S006
Product code: MVD
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Decision date: 2012-06-08
Decision code: APPR
Date received: 2011-12-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 FISH PHARMDX KIT AND ITS INDICATION FOR USE IS: A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TOQUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST AND GASTRIC CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED AND FOR BREAST CANCER PATIENTS FOR WHOM PERJETA (PERTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).