INSITE HER-2/NEU KIT

FDA premarket approval P040030 · decided 2004-12-22

Approval details

PMA number

P040030

Trade name

INSITE HER-2/NEU KIT

Generic name

SYSTEM, TEST, HER-2/NEU, IHC

Applicant

Biogenex Laboratories, Inc.

Date received

2004-06-22

Decision date

2004-12-22

Days to decision

183 days

Decision code

APWD

Product code

MVC

Advisory committee

Pathology

Expedited review

No

Location

San Ramon, CA

Statement

APPROVAL FOR THE INSITE HER-2/NEU KIT. THE DEVICE IS INDICATED FOR: INSITE HER-2/NEU MOUSE MONOCLONAL ANTIBODY (CLONE CB11) KIT IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN IMMUNOHISTOCHEM-ISTRY (IHC) ASSAYS TO SEMI-QUANTITATIVELY LOCALIZED BY LIGHT MICROSCOPY THE OVER-EXPRESSION OF HER-2/NEU (I.E., C-ERBB-2) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE SECTIONS. INSITE HER-2/NEU IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB