Cleared Traditional

K230827 - HardyDisk AST Rezafungin 5µg (RZF5)

K230827 is the FDA 510(k) clearance for HardyDisk AST Rezafungin 5µg (RZF5) by Hardy Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K230827 · Hardy Diagnostics · Microbiology device
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Jun 2023
Decision
66d
Days
Class 2
Risk

K230827 is an FDA 510(k) clearance for the HardyDisk AST Rezafungin 5µg (RZF5). 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 June 1, 2023 after a review of 66 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 K230827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2023
Decision Date June 01, 2023
Days to Decision 66 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
36d faster than avg
Panel avg: 102d · This submission: 66d
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 K230827.
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · Oxoid Limited (Part of Thermo Fisher Scientific) · Oct 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · Hardy Diagnostics · Jul 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
K230651 · Becton, Dickinson and Company · Jun 2023
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · Becton, Dickinson and Company · Dec 2022
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