Identity
- Trade Name
- BIOMERIEUX THXID BRAF ASSAY KIT FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P120014 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APWD FDA PMA
The THXID BRAF Kit is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. It is a real-time PCR test designed for use on the ABI 7500 Fast DX Real-Time PCR Instrument.
The device is intended to aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib (Tafinlar®) and to aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib (Mekinist). It is supplied as a kit for use in clinical laboratory settings under FDA PMA authorization.
Frequently asked questions
What type of specimen is required for the THXID BRAF Kit?
The THXID BRAF Kit requires DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue for the qualitative detection of BRAF V600E and V600K mutations.
Which instrument is the THXID BRAF Kit designed to be used with?
The THXID BRAF Kit is intended to be used as a real-time PCR test on the ABI 7500 Fast DX Real-Time PCR Instrument, as specified in the approval documentation.
What clinical purpose does the THXID BRAF Kit serve in melanoma treatment selection?
The THXID BRAF Kit aids in selecting melanoma patients with BRAF V600E mutation for dabrafenib (Tafinlar®) treatment and those with BRAF V600E or V600K mutation for trametinib (Mekinist) treatment, serving as a companion diagnostic.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120014 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
- FDA Applicant
- bioMerieux, Inc.
Sources (1)
- FDA PMA P120014 24 fields · synced Oct 6, 2026