Cleared Traditional

K250789 - Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

K250789 is an FDA 510(k) clearance for Thermo Scientific Oxoid Aztreonam/Aviba..., manufactured by Thermo Fisher Scientific (Oxoid Ltd.). The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Microbiology device
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Jun 2025
Decision
90d
Days
Class 2
Risk

K250789 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Oxoid Ltd.) (Basingstoke, GB). The FDA issued a Cleared decision on June 12, 2025 after a review of 90 days - within the typical 510(k) review window.

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 Thermo Fisher Scientific (Oxoid Ltd.) devices

FDA 510(k) Submission Details - K250789

510(k) Number K250789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2025
Decision Date June 12, 2025
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 K250789.
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