# K023677: Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV)

- Pathway: 510(k) (Traditional)
- Applicant: Osmetech
- Decided: Jan 29, 2003 after 89 days
- Product code: LIB (Device, General Purpose, Microbiology, Diagnostic)
- 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
Longest line of descent: 1 generation back to K011043 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011043: Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti), Osmetech (2001)

## Indications for use
The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMATM-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence by semi-quantitative analysis of volatile compounds released into the headspace above a high vaginal swab. The OMATM-BV is indicated for use as an adjunct for the diagnosis of Bacterial vaginosis (BV). The device may be used together with other clinical and patient information when diagnosing BV including pH, vaginal discharge characteristics, amine odor and clue cells or gram stain procedures that are currently commonly used to diagnose infection.

Source page: https://510kreport.com/device/K023677
Methodology: https://510kreport.com/methodology