TruSight Oncology Comprehensive
FDA premarket approval P230011 · decided 2024-08-21
Approval details
- PMA number
- P230011
- Trade name
- TruSight Oncology Comprehensive
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Illumina, Inc.
- Date received
- 2023-03-20
- Decision date
- 2024-08-21
- Days to decision
- 520 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina® NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi- nucleotide variants, insertions, and deletions from DNA, and fusions in 24 genes and s
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MISEQDX UNIVERSAL KIT 1.0 (DEN130042) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (K124006) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX PLATFORM (DEN130011) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (K132750) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA BEADXPRESS SYSTEM (K093128) | Illumina, Inc. | 2010-04-28 |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (K093129) | Illumina, Inc. | 2010-04-28 |