Cleared Traditional

K190914 - MTS Doxycycline 0.016 - 256 µg/mL

K190914 is the FDA 510(k) clearance for MTS Doxycycline 0.016 - 256 µg/mL by Liofilchem S. R. L.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K190914 · Liofilchem S. R. L. · Microbiology device
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May 2019
Decision
51d
Days
Class 2
Risk

K190914 is an FDA 510(k) clearance for the MTS Doxycycline 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 May 29, 2019 after a review of 51 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

Submission Details

510(k) Number K190914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2019
Decision Date May 29, 2019
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.
Anne R Windau

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

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