# K011043: Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)

- Pathway: 510(k) (Traditional)
- Applicant: Osmetech
- Decided: Nov 30, 2001 after 239 days
- Product code: JXA (Kit, Screening, Urine)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023677: Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV) (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K011043
Methodology: https://510kreport.com/methodology