Product code SBY— Pathology
PGDx elio plasma focus Dx
- Classification name
- High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
- Device class
- Class 2
- Regulation
- 21 CFR 866.6085
- Advisory panel
- Pathology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.”
Market context for product code SBY
FDA has cleared device under product code SBY, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SBY
Recent clearances under product code SBY
Data sourced from openFDA. This site is unofficial and independent of the FDA.