| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | SPOT-LIGHT HER2 CISH KIT |
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| Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
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| Applicant | INVITROGEN CORPORATION
3175 STALEY RD.
GRAND ISLAND, NY 14072 |
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| PMA Number | P050040 |
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| Date Received | 11/03/2005 |
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| Decision Date | 07/01/2008 |
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Withdrawal Date
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01/07/2015 |
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| Product Code |
NYQ |
| Docket Number | 08M-0437 |
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| Notice Date | 07/31/2008 |
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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 SPOT-LIGHT HER2 CISH KIT. THIS DEVICE IS INDICATED FOR: THE SPOT-LIGHT HER2 CISH KIT IS INTENDED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CARCINOMA TISSUE SECTIONS USING CHROMOGENIC IN SITU HYBRIDIZATION (CISH) AND BRIGHTFIELD MICROSCOPY. THIS TEST SHOULD BE PERFORMED IN A HISTOPATHOLOGY LABORATORY. THE SPOT-LIGHT HER2 CISH KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. THE ASSAY RESULTS ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGICAL INFORMATION CURRENTLY BEING USED AS PART OF THE MANAGEMENT OF BREAST CANCER PATIENTS. INTERPRETATION OF TEST RESULTS MUST BE MADE WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY BY A QUALIFIED PATHOLOGIST. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S003 |
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