# DEN200001: Cell-Free DNA BCT

- Pathway: De Novo (Direct)
- Applicant: Streck, Inc.
- Decided: Aug 7, 2020 after 210 days
- Product code: QMA (Blood Collection Device For Cell-Free Nucleic Acid)
- Device class: 2
- Regulation: 21 CFR 862.1676
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next-generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

Source page: https://510kreport.com/device/DEN200001
Methodology: https://510kreport.com/methodology