Pathology · PMA · 2023
xT CDx
Tempus Labs, Inc.. Approved by FDA on 28 April 2023 under submission P210011, product code PQP (next generation sequencing oncology panel, somatic or germline variant detection system). What FDA's record says, in FDA's words.
Device record · P210011
- Device. xT CDxDEVICE
- Company. Tempus Labs, Inc.COMPANY
- Decision. 28 April 2023, PMA, apprDECISION
- Panel. PathologyPANEL
- Product code. PQP, Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemCODE
- Source. FDA database entry · decision document (107 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus Labs, Inc., Chicago, IL. PMA P210011: FDA Summary of Safety and Effectiveness Data 1 of 107 Companion diagnostic indications Tumor Type Biomarker(s) Detected Therapy Colorectal cancer (CRC) KRAS wild type (absence of mutations in […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 14 reports filed against devices carrying product code PQP. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
13 May 2026 · Malfunction · ONCOMINE¿ DX EXPRESS TEST · LIFE TECHNOLOGIES CORPORATION · report 3003335080-2026-00001
IT HAS BEEN DISCOVERED THAT THE ONCOMINE DX EXPRESS TEST (ODXET) MAY NOT DETECT THE FGFR3 C.746C>G P.S249C (COSM715) VARIANT WHEN PRESENT IN A SAMPLE AT VERY LOW ALLELIC FREQUENCIES (AFS) DUE TO A SECONDARY STRUCTURE FORMATION THAT INHIBITS AMPLIFICATION OF THE MUTANT ALLELE, WHICH MAY RESULT IN FALSE-NEGATIVE RESULTS FOR THIS SPECIFIC FGFR3 VARIANT DUE TO AF MEASUREMENT FALLING BELOW THE VARIANT CALLING THRESHOLD. PREDICTIVE MODELING INDICATES THIS IS DRIVEN BY HIGH GUANINE AND CYTOSINE (GC) […]
3 April 2026 · Malfunction · FOUNDATIONONECDX · FOUNDATION MEDICINE, INC. · report 3010679023-2026-00004
ON 31 JAN 2026, THE FOUNDATION MEDICINE, CLINICAL BIOINFORMATICS OPERATIONS (CBO) TEAM FLAGGED DNA SEQUENCING MASTER POOL (B)(6) (ANALYSIS WORKFLOW: (B)(6)_MPL (B)(6) PROD) FOR THE PRESENCE OF POTENTIAL BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS. THE INVESTIGATION DETERMINED THAT AN INCREASED FREQUENCY OF BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS, PRESENT IN A HOMOPOLYMER SEQUENCE REGION, WAS CORRELATED WITH THE USE OF SUPPLIER PROVIDED REAGENT SEQ0067 WITH LOT NUMBERS 24346, 24386, 24488. SIX […]
2 April 2026 · Malfunction · FOUNDATIONONECDX · FOUNDATION MEDICINE, INC. · report 3010679023-2026-00002
ON 31 JAN 2026, THE FOUNDATION MEDICINE, CLINICAL BIOINFORMATICS OPERATIONS (CBO) TEAM FLAGGED DNA SEQUENCING MASTER POOL (B)(6) (ANALYSIS WORKFLOW: (B)(6) PROD) FOR THE PRESENCE OF POTENTIAL BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS. THE INVESTIGATION DETERMINED THAT AN INCREASED FREQUENCY OF BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS, PRESENT IN A HOMOPOLYMER SEQUENCE REGION, WAS CORRELATED WITH THE USE OF SUPPLIER PROVIDED REAGENT SEQ0067 WITH LOT NUMBERS: 24346, 24386, 24488. SIX (6) F1CDX […]
2 April 2026 · Malfunction · FOUNDATIONONECDX · FOUNDATION MEDICINE, INC. · report 3010679023-2026-00006
ON 31 JAN 2026, THE FOUNDATION MEDICINE, CLINICAL BIOINFORMATICS OPERATIONS (CBO) TEAM FLAGGED DNA SEQUENCING MASTER POOL (B)(4) FOR THE PRESENCE OF POTENTIAL BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS. THE INVESTIGATION DETERMINED THAT AN INCREASED FREQUENCY OF BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS, PRESENT IN A HOMOPOLYMER SEQUENCE REGION, WAS CORRELATED WITH THE USE OF SUPPLIER PROVIDED REAGENT SEQ0067 WITH LOT NUMBERS 24346, 24386, 24488. SIX (6) F1CDX REPORTS ASSOCIATED WITH THE USE OF […]
2 April 2026 · Malfunction · FOUNDATIONONECDX · FOUNDATION MEDICINE, INC. · report 3010679023-2026-00001
ON 31 JAN 2026, THE FOUNDATION MEDICINE, CLINICAL BIOINFORMATICS OPERATIONS (CBO) TEAM FLAGGED DNA SEQUENCING MASTER POOL (B)(6) (ANALYSIS WORKFLOW: (B)(6) PROD) FOR THE PRESENCE OF POTENTIAL BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS. THE INVESTIGATION DETERMINED THAT AN INCREASED FREQUENCY OF BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS, PRESENT IN A HOMOPOLYMER SEQUENCE REGION, WAS CORRELATED WITH THE USE OF SUPPLIER PROVIDED REAGENT SEQ0067 WITH LOT NUMBERS: 24346, 24386, 24488. SIX (6) F1CDX […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PQP, in Pathology, or approved in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.