510(k) Report

510(k) · Cleared

Cleared

Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV)

K023677510(k) TraditionalCleared Jan 29, 200389-day reviewClass I21 CFR 866.2660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osmetech · LIB Device, General Purpose, Microbiology, Diagnostic

Cleared on Jan 29, 2003 as substantially equivalent to K011043 (Osmetech, 2001) after an 89-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jan 29, 2003
Review
89 days
Class
Class I
Product code
LIB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011043 (2001). No later device cites it as a predicate yet.

K011043 · Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti) · Osmetech · 2001200020022004
K011043 · Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti) · Osmetech · 20010
  1. Root · 1 generation backK011043 Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)Osmetech · 2001
  2. This deviceK023677 Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV)Osmetech · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011043Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)Osmetech2001—
0 (this device)K023677Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV)Osmetech2003—
FIG. 1 — Lineage of K023677, 2001–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K011043Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)Osmetech2001—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All LIB devices

LIB Device, General Purpose, Microbiology, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIB

FDA has decided no LIB device since 2007.

Median 510(k) review, days · LIB

Too few LIB 510(k)s in any year since 2007 to give a median.

Recalls per year · LIB

1in 2025

2007: 22014: 22016: 12025: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LIB

1in 2025

2016: 32017: 12023: 22025: 1
2007high 3 (2016) · low 0 (2007)2025

MAUDE reports naming product code LIB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—20
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—20
20150—00
20160—13
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—02
20240—00
20250—11
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Osmetech

2 FDA decisions under this applicant name. See the company

  • K011043Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)Osmetech · 2001

Recent decisions in LIB

The LIB category page

  • K920416Supplementary Reagents for Enzygnost/TMBBehring Diagnostics, Inc. · 1992
  • K912558Gull ElisawareGull Laboratories, Inc. · 1991
  • K872273Corning Easy Wash Elisa PlatesCorning Medical & Scientific · 1987
  • K871559Cell LifterCorning Costar Corp. · 1987
  • K864249Normal Saline SterileMds Laboratories, Inc. · 1987

https://510kreport.com/device/K023677 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023677: Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023677

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026