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FDA PRODUCT CODE · CLASS III

PQP — Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
11
510(K)/PMA CLEARANCES
pma: 11
0
RECALL ENTRIES

Recent clearances

P200010Guardant Health, Inc. · pma2026-07-14
P250027Guardant Health, Inc. · pma2026-07-06
P240010Caris Life Sciences · pma2026-07-02
P230011Illumina, Inc. · pma2026-06-26
P240040Life Technologies Corporation · pma2026-06-08
P210011Tempus Labs, Inc. · pma2026-05-28
P190032Foundation Medicine, Inc. · pma2026-05-27
P170019Foundation Medicine, Inc. · pma2026-05-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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