Ventana ALK (D5f3) CDx Assay
FDA premarket approval P140025/S010 · decided 2018-12-07
Approval details
- PMA number
- P140025
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ventana ALK (D5f3) CDx Assay
- Generic name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2018-11-09
- Decision date
- 2018-12-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PKW
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Change to purification technology for one of the assay components and improvement in incoming quality control.
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510(k) clearances by this applicant
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|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
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| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
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| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |