myChoice CDx
FDA premarket approval P190014/S002 · decided 2020-03-23
Approval details
- PMA number
- P190014
- Supplement
- S002
- Supplement type
- Real-Time Process
- 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
- 2020-02-05
- Decision date
- 2020-03-23
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval of the final revised labeling (IU) for the Myriad myChoice® CDx. The device 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 boundaries of the BRCA1 and BRCA2 genes and the determination of Genomic Instability Score (GIS) which is an algorithmic measurement of Loss of Heterozygosity (L
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