SPOT-LIGHT HER2 CISH KIT
FDA premarket approval P050040 · decided 2008-07-01
Approval details
- PMA number
- P050040
- Trade name
- SPOT-LIGHT HER2 CISH KIT
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Invitrogen Corporation
- Date received
- 2005-11-03
- Decision date
- 2008-07-01
- Days to decision
- 971 days
- Decision code
- APWD
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Grand Island, NY
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) | Invitrogen Corporation | 2002-12-23 |