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Device | HER2 CISH PHARMDX KIT |
Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
Applicant | DAKO DENMARK A/S 42 PRODUKTIONSVEJ DK-2600 GLOSTRUP DK-26-2600 |
PMA Number | P100024 |
Date Received | 06/21/2010 |
Decision Date | 11/30/2011 |
Withdrawal Date
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01/24/2018 |
Product Code |
NYQ |
Docket Number | 11M-0866 |
Notice Date | 12/09/2011 |
Advisory Committee |
Pathology |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE HER2 CISH PHARMDX KIT. THIS DEVICE IS INDICATED TOR;HER2 CISH PHARMDX KIT IS INTENDED FOR DUAL-COLOR CHROMOGENIC VISUALIZATION OF SIGNALS ACHIEVED WITH DIRECTLY LABELED IN SITU HYBRIDIZATION PROBES TARGETING THE HER2 GENE AND CENTROMERIC REGION OF CHROMOSOME 17. THE KIT IS DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE STATUS IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. RED AND BLUE CHROMOGENIC SIGNALS ARE GENERATED ON THE SAME TISSUE SECTION FOR EVALUATION UNDER BRIGHT FIELD MICROSCOPY. THE CISH PROCEDURE IS AUTOMATED USING DAKO AUTOSLAINERINSTRUMENTS. HER2 CISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FROM THE HER2 CISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATIONCURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 |