Oncomine Dx Target Test
FDA premarket approval P160045/S031 · decided 2022-09-21
Approval details
- PMA number
- P160045
- Supplement
- S031
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Oncomine Dx Target Test
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Life Technologies Corporation
- Date received
- 2021-09-24
- Decision date
- 2022-09-21
- Days to decision
- 362 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of the identification of RET fusions in NSCLC patients, RET mutations in medullary thyroid cancer (MTC) patients and RET fusions in thyroid cancer (TC) patients who may benefit from RETEVMO® (selpercatinib).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (K241806) | Life Technologies Corporation | 2025-01-08 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (K191030) | Life Technologies Corporation | 2020-02-21 |
| Ion PGM Dx System (K170299) | Life Technologies Corporation | 2017-06-22 |
| QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955) | Life Technologies Corporation | 2013-03-08 |
| STEMPRO MSC SFM (K103302) | Life Technologies Corporation | 2011-02-18 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |