# P160045: Oncomine Dx Target Test

- Pathway: PMA
- Applicant: Life Technologies Corporation
- Decided: Jun 22, 2017 after 248 days
- Product code: PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 16, 2020 · Class II · Z-1705-2020: Extended Expiration Date prior to clearance
- Mar 16, 2020 · Class II · Z-1706-2020: Extended Expiration Date prior to clearance
- Mar 16, 2020 · Class II · Z-1707-2020: Extended Expiration Date prior to clearance
- Mar 16, 2020 · Class II · Z-1704-2020: Extended Expiration Date prior to clearance
- Feb 8, 2018 · Class II · Z-1480-2018: The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excl
- Dec 4, 2017 · Class II · Z-1279-2018: The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.

Source page: https://510kreport.com/device/P160045
Methodology: https://510kreport.com/methodology