Identity
- Trade Name
- TruSight Oncology Comprehensive FDA PMA
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system FDA PMA
Identifiers
- PMA Number
- P230011 FDA PMA
- FDA Product Code
- PQP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test classified as a next-generation sequencing oncology panel for somatic or germline variant detection. It employs targeted sequencing to identify genetic variants—including single nucleotide variants, multi-nucleotide variants, insertions, deletions, fusions in 24 genes, and splice variants in one gene—from nucleic acids extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. The test also calculates a Tumor Mutational Burden (TMB) score to assess genomic instability, supporting precision oncology assessments for solid malignant neoplasms.
This test is performed using the Illumina® NextSeq™ 550Dx instrument and is intended for use as a companion diagnostic to guide treatment decisions for therapies listed in the approved labeling. It is supplied as a reagent kit for laboratory use, requiring extraction of nucleic acids from FFPE samples prior to sequencing. The device is classified as Class III under FDA regulations and holds a PMA approval (P230011). No sterility or single-use specifications are stated, but compliance with laboratory protocols for nucleic acid extraction and sequencing is required.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230011 | Class III | Active |
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Manufacturer
- Manufacturer
- Illumina, Inc.
Sources (1)
- FDA PMA P230011 23 fields · synced Sep 18, 2026