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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRoche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP110020
Supplement NumberS016
Date Received06/30/2016
Decision Date11/07/2016
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cobas® 4800 BRAF V600 Mutation Test. The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas® 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling: Therapeutic Therapeutic Indication Test ResultZELBORAF® (vemurafenib) BRAF V600E Mutation DetectedCOTELLIC® (cobimetinib), in combination with ZELBORAF® (vemurafenib) BRAF V600E or V600K* Mutation Detected* *Due to cross-reactivity by the cobas® 4800 BRAF V600 Mutation Test, the clinical trial for cobimetinib, in combination with vemurafenib, included some patients whose tumor carried the BRAF V600K mutation.
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