Cleared Traditional

K151873 - Etest Ceftaroline (0.002 - 32ug/ml)

K151873 is an FDA 510(k) clearance for Etest Ceftaroline (0.002 - 32ug/ml), manufactured by Biomerieux S.A.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K151873 · Biomerieux S.A. · Microbiology device
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Oct 2015
Decision
90d
Days
Class 2
Risk

K151873 is an FDA 510(k) clearance for the Etest Ceftaroline (0.002 - 32ug/ml). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on October 7, 2015 after a review of 90 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 Biomerieux S.A. devices

FDA 510(k) Submission Details - K151873

510(k) Number K151873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2015
Decision Date October 07, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
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 Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 392
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K151873.
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · Liofilchem S. R. L. · Jun 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · Liofilchem S. R. L. · Mar 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
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc. · Sep 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
K150556 · Thermo Fisher Scientific · Aug 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
K150236 · Thermo Fisher Scientific · Jul 2015