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| Device | INSITE HER-2/NEU KIT |
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| Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
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| Applicant | BIOGENEX LABORATORIES, INC.
4600 NORRIS CANYON RD.
SAN RAMON, CA 94583 |
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| PMA Number | P040030 |
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| Date Received | 06/22/2004 |
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| Decision Date | 12/22/2004 |
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Withdrawal Date
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03/15/2006 |
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| Product Code |
MVC |
| Docket Number | 05M-0160 |
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| Notice Date | 05/02/2005 |
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| Advisory Committee |
Pathology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order 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) THERAPY IS BEING CONSIDERED. CLINICAL INTERPRETATION OF INSITE HER-2/NEU IMMUNOSTAINING RESULTS (ABSENCE OR PRESENCE; SEMI-QUANTITATIVE INTENSITY SCORE) SHOULD BE COMPLEMENTED BY APPROPRIATE CONTROLS AND MORPHOLOGICAL TISSUE ANALYSIS AND BE EVALUATED BY A QUALIFIED PATHOLOGIST WITHIN THE CONTEXT OF PATIENT CLINICAL HISTORY AND OTHER DIAGNOSTIC RESULTS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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