FDA Product Code SBY: High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids
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.
Leading manufacturers include Personal Genome Diagnostics, Inc..
FDA 510(k) Cleared High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids Devices (Product Code SBY)
About Product Code SBY - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBY since 2024, with 0 receiving FDA clearance (average review time: 398 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBY devices are reviewed by the Pathology panel. Browse all Pathology devices →