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.
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) 180-day supplement, which requested 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.
| Device | VENTANA ALK (D5F3) CDx Assay |
| Generic Name | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2020-11-16 |
| Decision Date | 2021-03-03 |
| PMA | P140025 |
| Supplement | S014 |
| Product Code | PKW |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140025 | Original Filing | |
| S018 | 2022-07-12 | 30-day Notice |
| S017 | 2022-02-16 | Special (immediate Track) |
| S016 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S015 | 2021-02-22 | Real-time Process |
| S014 | 2020-11-16 | Normal 180 Day Track |
| S013 | 2020-08-26 | Real-time Process |
| S012 | 2020-01-13 | Real-time Process |
| S011 | 2019-08-22 | Real-time Process |
| S010 | 2018-11-09 | 30-day Notice |
| S009 | 2018-06-18 | Real-time Process |
| S008 | ||
| S007 | 2017-07-17 | 30-day Notice |
| S006 | 2017-06-07 | Normal 180 Day Track |
| S005 | 2016-12-28 | Normal 180 Day Track |
| S004 | 2016-11-15 | Normal 180 Day Track |
| S003 | 2016-03-22 | Normal 180 Day Track |
| S002 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S001 | 2015-08-26 | 30-day Notice |