Cleared Traditional

K080019 - HARDYDISK AST DORIPENEM 10 UG

K080019 is the FDA 510(k) clearance for HARDYDISK AST DORIPENEM 10 UG by Hardy Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K080019 · Hardy Diagnostics · Microbiology device
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Jan 2008
Decision
26d
Days
Class 2
Risk

K080019 is an FDA 510(k) clearance for the HARDYDISK AST DORIPENEM 10 UG. 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 January 29, 2008 after a review of 26 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 K080019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2008
Decision Date January 29, 2008
Days to Decision 26 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
76d faster than avg
Panel avg: 102d · This submission: 26d
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 K080019.
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · Becton, Dickinson & CO · Oct 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · Becton, Dickinson & CO · Oct 2008
DORIPENEM 10UG BBL SENSI-DISC
K080998 · Becton, Dickinson & CO · May 2008
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K070262 · Oxoid , Ltd. · Mar 2007
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · Hardy Diagnostics · Aug 2006
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K060286 · Oxoid , Ltd. · Mar 2006