| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | VENTANA ALK (D5F3) CDx Assay |
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| Generic Name | Immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
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| Applicant | VENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755 |
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| PMA Number | P140025 |
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| Supplement Number | S014 |
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| Date Received | 11/16/2020 |
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| Decision Date | 03/03/2021 |
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| Product Code |
PKW |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT03052608
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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Approval Order Statement
Approval for inclusion of an indication for LORBRENA ((lorlatinib). The device will be marketed under the trade name VENTANA ALK (D5F3) CDx Assay and is indicated for:VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), or ALECENSA® (alectinib) or LORBRENA® (lorlatinib).This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use. |
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