# K070062: Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General Use

- Pathway: 510(k) (Traditional)
- Applicant: Diesse Diagnostica Senese S.P.A.
- Decided: Jul 30, 2007 after 206 days
- Product code: LIO (Device, Specimen Collection)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K781304 (1978). 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)
- K781304: Transport Media, Bd Becton Dickinson Vacutainer Systems Preanalytic (1978) Summary page 3.
- K024240: BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits, Bd (2003) Summary page 3.

## Indications for use
In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.

Source page: https://510kreport.com/device/K070062
Methodology: https://510kreport.com/methodology