PMA P980018S015

Device: HERCEP TEST
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P980018
Supplement: S015
Product code: MVC
Decision date: 2012-06-08
Classification: System, Test, Her-2/neu, Ihc
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement: APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HERCEPTEST. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HERCEPTEST AND ITS INDICATION FOR USE IS: HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOHISTO-CHEMICAL ASSAY TO DETERMINE HER2 PROTEIN OVEREXPRESSION IN BREAST CANCER TISSUES ROUTINELY PROCESSED FOR HISTOLOGICAL EVALUATION AND FORMALIN-FIXED, PARAFFIN-EMBEDDED CANCER TISSUE FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HERCEPTEST 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 BEINGCONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).

Current openFDA PMA Record#

Device: HERCEP TEST
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P980018
Supplement: S015
Product code: MVC
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
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 HERCEPTEST. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HERCEPTEST AND ITS INDICATION FOR USE IS: HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOHISTO-CHEMICAL ASSAY TO DETERMINE HER2 PROTEIN OVEREXPRESSION IN BREAST CANCER TISSUES ROUTINELY PROCESSED FOR HISTOLOGICAL EVALUATION AND FORMALIN-FIXED, PARAFFIN-EMBEDDED CANCER TISSUE FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HERCEPTEST 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 BEINGCONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).