Oncomine Dx Target Test
FDA premarket approval P160045/S045 · decided 2024-06-17
Approval details
- PMA number
- P160045
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- 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
- 2023-12-20
- Decision date
- 2024-06-17
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval to update the user guide and promotional materials for the Oncomine Dx Target Test to include the results of the study data as recommended by FDA in P160045/R011, P160045/R017, P160045/R018, P160045/R025, P160045/R028, P160045/R030, and P160045/R031.
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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 |