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 next-generation sequencing test that analyzes cell-free nucleic acids from plasma of peripheral whole blood to detect mutations in targeted gene panels, aiding in the management of previously diagnosed cancer patients by qualified healthcare professionals; results are not prescriptive for specific therapeutic products. It is classified as FDA Class II (510(k) required) under regulation 866.6085 in the Pathology specialty, with product code SBY. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SBY
- Device Class
- FDA class 2
- Regulation Number
- 866.6085
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230046 | PGDx elio plasma focus Dx | Aug 01, 2024 | Unknown | Personal Genome Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.