510(k) K192063
K192063 is an FDA 510(k) premarket notification submitted by Personal Genome Diagnostics for the device "PGDx elio tissue complete". The FDA issued a decision of Substantially Equivalent on April 24, 2020. The device falls under product code PZM (Next Generation Sequencing Based Tumor Profiling Test), a Class II device regulated under 21 CFR 866.6080. Personal Genome Diagnostics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2020
- Date Received
- August 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Next Generation Sequencing Based Tumor Profiling Test
- Device Class
- Class II
- Regulation Number
- 866.6080
- Review Panel
- PA
- Submission Type
A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.