Cleared Traditional

K250789 - Thermo Scientific Oxoid Aztreonam/Aviba...

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

K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K250789.
Sulopenem SPM 2 µg
K251879 · Liofilchem · Aug 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
K250956 · Hardy Diagnostics · Jun 2025
Ceftobiprole BPR 5 µg Disc
K250885 · Liofilchem, Inc. · Jun 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · Hardy Diagnostics · May 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · Hardy Diagnostics · Jul 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · Oxoid Limited (Part of Thermo Fisher Scientific) · Mar 2024