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K Number
K093604
Device Name
ETEST MOXIFLOXACIN 0.002-32 UG/ML
Manufacturer
AB BIOMERIEUX
Date Cleared
2010-08-25

(278 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for a medical device (Etest® Moxifloxacin for Antimicrobial Susceptibility Testing, K093604), not a study report. Therefore, the provided text does not contain the acceptance criteria or study details that typically accompany a device performance study.

Here's why and what information is missing:

  • Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices, but it does not specify any quantitative performance metrics or acceptance criteria that were used to establish this equivalence. It's a regulatory clearance, not a scientific publication of a study's results.
  • Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set details: These are all aspects of a detailed study design and results. The 510(k) letter only confirms the device's clearance for marketing.

To get the information requested, one would typically need to consult a separate document, often referred to in the 510(k) summary as a "clinical study report" or "performance data." This letter itself does not provide those details.

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).