FDA product code SBY: High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

SBY is the FDA product code for high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids. It is a Class II device, regulated under 21 CFR 866.6085 and reviewed by the Pathology panel. Devices under SBY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for SBY devices

openFDA lists no recalls for product code SBY.

Frequently asked questions

What is FDA product code SBY?

SBY is the FDA product code for high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids. It is a Class II device, regulated under 21 CFR 866.6085 and reviewed by the Pathology panel.

What device class is SBY?

Class II, regulation 21 CFR 866.6085. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SBY
• Run a recall and safety report across every SBY manufacturer
• Watch product code SBY for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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