# P210040: RESOLUTION ctDx FIRST

- Pathway: PMA
- Applicant: Exact Sciences Corporation
- Decided: Dec 12, 2022 after 349 days
- Product code: PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 17, 2023 · Class III · Z-1358-2023: Distributed sample collection kit with an unapproved instruction for use.

Source page: https://510kreport.com/device/P210040
Methodology: https://510kreport.com/methodology