Cleared Traditional

K153687 - Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

K153687 is an FDA 510(k) clearance for Liofilchem MIC Test Strip (MTS)-Vancomy..., 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 99-day FDA review.

K153687 · Liofilchem S. R. L. · Microbiology device
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Mar 2016
Decision
99d
Days
Class 2
Risk

K153687 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Liofilchem S. R. L. (Abruzzi, IT). The FDA issued a Cleared decision on March 31, 2016 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Liofilchem S. R. L. devices

FDA 510(k) Submission Details - K153687

510(k) Number K153687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date March 31, 2016
Days to Decision 99 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
3d faster than avg
Panel avg: 102d · This submission: 99d
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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K153687.
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
K162854 · Liofilchem S. R. L. · Dec 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
K161175 · Liofilchem S. R. L. · Jul 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · Liofilchem S. R. L. · Jun 2016
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
K152774 · Thermo Fisher Scientific · Dec 2015
Etest Ceftaroline (0.002 - 32ug/ml)
K151873 · Biomerieux S.A. · Oct 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc. · Sep 2015