Cleared Traditional

K023677 - OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)

K023677 is an FDA 510(k) clearance for OSMETECH MICROBIAL ANALYSER-BACTERIAL V..., manufactured by Osmetech. The device is a Class 1 Microbiology device with product code LIB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K023677 · Osmetech · Microbiology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K023677

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.

LIB Device Classification - Class 1, General Controls

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.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 30
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K023677.
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