Cleared Traditional

K203336 - Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

K203336 is an FDA 510(k) clearance for Thermo Scientific Oxoid Omadacycline Di..., manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 672-day FDA review.

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

FDA 510(k) Submission Details - K203336

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
Combination Product No
PCCP Authorized No
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.

JTN Device Classification - Class 2, Special Controls

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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K203336.
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K203700 · Oxoid Limited (Part of Thermo Fisher Scientific) · Jul 2021
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