Device product
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
Z-1279-2018
Product summary
- Event
- Event 79437
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-1279-2018
Official wording
Reason: 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.
Code information: Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017) UDI: (01)10190302006071
Distribution pattern: US Distribution to the states of: AZ, CA, NC, TX, and VA.
Derived failure modes
-
Unknown
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.