# K230035: BioSci™  Disposable Virus Sampling Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.
- Decided: Apr 5, 2023 after 90 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910526 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042970: Copan Universal Transport Medium (Utm-RT) System, Copan Diagnostics, Inc. (2004) Summary page 4.

## Indications for use
BioSci™ Disposable Virus Sampling Tube is intended for the collection and transport of clinical specimens containing viruses or chlamydiae from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.

Source page: https://510kreport.com/device/K230035
Methodology: https://510kreport.com/methodology