# K220059: Biosci™ Inactivated Transport Medium, Biosci™ ITM

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.
- Decided: Jan 19, 2023 after 374 days
- Product code: QBD (Microbial Nucleic Acid Storage And Stabilization Device)
- Device class: 2
- Regulation: 21 CFR 866.2950
- 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 DEN170029 (2018). 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)
- K201849: eNAT molecular collection and preservation medium, Copan Italia Spa (2020) Summary page 4.

## Indications for use
Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, inactivation, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.

Source page: https://510kreport.com/device/K220059
Methodology: https://510kreport.com/methodology