Cleared Traditional

K181708 - MTS Plazomicin 0.016-256 µg/mL

K181708 is an FDA 510(k) clearance for MTS Plazomicin 0.016-256 µg/mL, manufactured by Liofilchem S. R. L.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K181708 · Liofilchem S. R. L. · Microbiology device
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Jul 2018
Decision
33d
Days
Class 2
Risk

K181708 is an FDA 510(k) clearance for the MTS Plazomicin 0.016-256 µg/mL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi, IT). The FDA issued a Cleared decision on July 31, 2018 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Liofilchem S. R. L. devices

FDA 510(k) Submission Details - K181708

510(k) Number K181708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2018
Decision Date July 31, 2018
Days to Decision 33 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
69d faster than avg
Panel avg: 102d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 Consultant

Laboratory Specialists, Inc.
Laura M. Koeth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 391
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K181708.
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K181889 · Liofilchem S. R. L. · Sep 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
K181946 · Thermo Fisher Scientific · Aug 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
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Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
K180886 · Liofilchem S. R. L. · May 2018
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
K180339 · Liofilchem S. R. L. · Apr 2018