# K013819: Urine Collection, Preservation and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Sierra Diagnostic, LLC
- Decided: Feb 28, 2002 after 104 days
- Product code: JTW (System, Transport, Aerobic)
- 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 K934622 (1995). 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)
- K935833: LCX Neisseria Gonorrhoeae Assay, Abbott Laboratories (1996) Summary page 1.
- K934622: LCX Chlamydia Trachomatis Assay, Abbott Laboratories (1995) Summary page 1.

## Indications for use
The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is indicated for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays.

Source page: https://510kreport.com/device/K013819
Methodology: https://510kreport.com/methodology