Cleared Traditional

K193508 - Thermo Scientific Oxoid Eravacycline Di...

K193508 is the FDA 510(k) clearance for Thermo Scientific Oxoid Eravacycline Di... by Oxoid Limited (Part of Thermo Fisher Scientific). It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K193508 · Oxoid Limited (Part of Thermo Fisher Scientific) · Microbiology device
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Dec 2020
Decision
352d
Days
Class 2
Risk

K193508 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20. 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 December 4, 2020 after a review of 352 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K193508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2019
Decision Date December 04, 2020
Days to Decision 352 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
250d slower than avg
Panel avg: 102d · This submission: 352d
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 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K193508.
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · Oxoid Limited (Part of Thermo Fisher Scientific) · Sep 2022
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · Oxoid Limited (Part of Thermo Fisher Scientific) · Oct 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · Oxoid Limited (Part of Thermo Fisher Scientific) · Jul 2021
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · Hardy Diagnostics · Jan 2020
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · Hardy Diagnostics · Sep 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · Hardy Diagnostics · Jul 2019