Cleared Traditional

K250454 - HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (FDA 510(k) Clearance)

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

K250454 · Hardy Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
86d
Days
Class 2
Risk

K250454 is an FDA 510(k) clearance for the HardyDisk Aztreonam/Avibactam 30/20µg (AZA50). Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 15, 2025 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hardy Diagnostics devices

Submission Details

510(k) Number K250454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date May 15, 2025
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
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
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K250454.
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
K251337 · Thermo Fisher Scientific (Oxoid Ltd.) · Dec 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K253105 · Hardy Diagnostics · Nov 2025
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
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Jun 2025