Cleared Traditional

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (K023677) - FDA 510(k) Clearance

Class I Microbiology device.

K023677 · Osmetech · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
89d
Days
Class 1
Risk

K023677 is an FDA 510(k) clearance for the OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV). Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Osmetech (Crewe, GB). The FDA issued a Cleared decision on January 29, 2003 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osmetech devices

Submission Details

510(k) Number K023677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date January 29, 2003
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.