# K211707: BioTeke Sterile Disposable Virus Sampling Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bioteke Corporation (Wuxi) Co., Ltd.
- Decided: May 4, 2022 after 335 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: 4 generations back to K854986 (1986). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113249: Transport Culture Medium Device, Puritan Medical Products, LLC (2012) Summary page 6.
- K121039: Copan Mswab Collection, Transport and Preservation System, Copan Flock Technologies (2012) Summary page 6.

## Indications for use
The BioTeke Sterile Disposable Virus Sampling Kit is intended for the collection and transport of clinical specimens to the laboratory for standard diagnostic / identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including, Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.

Source page: https://510kreport.com/device/K211707
Methodology: https://510kreport.com/methodology