Cleared Traditional

K231806 - Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (FDA 510(k) Clearance)

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

K231806 · Oxoid Limited (Part of Thermo Fisher Scientific) · Microbiology device
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Mar 2024
Decision
276d
Days
Class 2
Risk

K231806 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5. 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 March 22, 2024 after a review of 276 days - an extended review cycle.

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. Standard predicate reliance. 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 K231806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2023
Decision Date March 22, 2024
Days to Decision 276 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 102d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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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