Devices · Tempus Labs, Inc.

xT CDx

Tempus Labs, Inc. is listed for xT CDx (P210011). The FDA list gives April 28, 2023 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the PMA pathway. openFDA describes product code PQP as “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. openFDA records decision code APPR for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210011

Official FDA database record

Date of final decision

April 28, 2023

Company on the FDA list

Tempus Labs, Inc.

Lead panel

Pathology

Primary product code

PQP

openFDA device name for the code

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

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

APPR

Statement or summary label

Statement