# P200006: FoundationOne Liquid CDx (F1 Liquid CDx)

- Pathway: PMA
- Applicant: Foundation Medicine, Inc.
- Decided: Oct 26, 2020 after 266 days
- Product code: PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System)
- Device class: 3
- Recalls of this device: 2 (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
- Jun 10, 2026 · Class II · Z-2951-2026: Software issue that can cause an increase in spontaneous software closures.
- Nov 8, 2022 · Class II · Z-0578-2026: Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Source page: https://510kreport.com/device/P200006
Methodology: https://510kreport.com/methodology