Cleared Traditional

K203336 - Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203336 · Oxoid Limited (Part of Thermo Fisher Scientific) · Microbiology device
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Sep 2022
Decision
672d
Days
Class 2
Risk

K203336 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Oxoid Limited (Part of Thermo Fisher Scientific) (Basingstoke, GB). The FDA issued a Cleared decision on September 15, 2022 after a review of 672 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Oxoid Limited (Part of Thermo Fisher Scientific) devices

Submission Details

510(k) Number K203336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2020
Decision Date September 15, 2022
Days to Decision 672 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
570d slower than avg
Panel avg: 102d · This submission: 672d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 326
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