TruSight Oncology Comprehensive
FDA premarket approval P230011/S005 · decided 2025-09-19
Approval details
- PMA number
- P230011
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TruSight Oncology Comprehensive
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Illumina, Inc.
- Date received
- 2025-08-26
- Decision date
- 2025-09-19
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- manufacturing process changes
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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 |