myChoice CDx
FDA premarket approval P190014/S001 · decided 2020-04-29
Approval details
- PMA number
- P190014
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- myChoice CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2020-01-23
- Decision date
- 2020-04-29
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for extending the label claim to include an additional indication for Zejula® (niraparib) maintenance therapy. The device, as modified, will be marketed under the trade name Myriad myChoice® CDx and is indicated for:Myriad myChoice® CDx is a next generation sequencing-based in vitro diagnostic test that assesses the qualitative detection and classification of single nucleotide variants, insertions and deletions, and large rearrangement variants in protein coding regions and intron/exon
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