RESOLUTION ctDx FIRST
FDA premarket approval P210040 · decided 2022-12-12
Approval details
- PMA number
- P210040
- Trade name
- RESOLUTION ctDx FIRST
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Exact Sciences Corporation
- Date received
- 2021-12-28
- Decision date
- 2022-12-12
- Days to decision
- 349 days
- Decision code
- APWD
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Madision, WI
- Statement
- Approval for the Agilent Resolution ctDx FIRST assay. The device is a qualitative next generation sequencing-based, in vitro diagnostic test that uses targeted hybrid-capture sequencing technology to detect and report single nucleotide variants (SNVs) and deletions in two genes. The Agilent Resolution ctDx FIRST assay utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended as a
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