therascreen® PIK3CA RGQ PCR Kit
FDA premarket approval P190001/S002 · decided 2025-10-22
Approval details
- PMA number
- P190001
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- therascreen® PIK3CA RGQ PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2024-05-03
- Decision date
- 2025-10-22
- Days to decision
- 537 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for a software update for the therascreen® PIK3CA RGQ PCR Kit
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K254032) | QIAGEN GmbH | 2026-03-09 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329) | QIAGEN GmbH | 2025-10-22 |
| QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080) | QIAGEN GmbH | 2025-08-27 |
| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
| QIAstat-Dx GI Panel 2 Mini B&V (K243813) | QIAGEN GmbH | 2025-01-08 |
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) | QIAGEN GmbH | 2024-10-29 |
| QIAstat-Dx Respiratory Panel Mini (K242353) | QIAGEN GmbH | 2024-10-25 |