# P170019: FoundationOne CDx

- Pathway: PMA
- Applicant: Foundation Medicine, Inc.
- Decided: Nov 30, 2017 after 181 days
- Product code: PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System)
- Device class: 3
- Recalls of this device: 9 (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.
- Mar 24, 2026 · Class II · Z-1937-2026: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
- Mar 20, 2026 · Class II · Z-1927-2026: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
- Apr 9, 2025 · Class II · Z-1747-2025: Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling
- Jun 18, 2024 · Class II · Z-1890-2025: Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved t
- Feb 15, 2023 · Class II · Z-1891-2025: An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
- Nov 8, 2022 · Class II · Z-0577-2026: 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.
- Aug 8, 2019 · Class II · Z-0535-2020: Identified potential false positive MSI-H on the test reports provided to the physicians.
- Oct 31, 2018 · Class II · Z-0649-2019: An incorrect test result for a single analyte may have been reported for up to 800 physician reports

Source page: https://510kreport.com/device/P170019
Methodology: https://510kreport.com/methodology