PMA P210011S004

Device: xT CDx
Applicant: Tempus Labs, Inc.
PMA number: P210011
Supplement: S004
Product code: PQP
Decision date: 2026-05-28
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Addition of an alternative method of germline subtraction and implementing an updated MSI caller in the bioinformatics pipeline.

Current openFDA PMA Record#

Device: xT CDx
Applicant: Tempus Labs, Inc.
PMA number: P210011
Supplement: S004
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-05-28
Decision code: APPR
Date received: 2025-06-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Addition of an alternative method of germline subtraction and implementing an updated MSI caller in the bioinformatics pipeline.