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K Number
K980348
Device Name
ETEST VANCOMYCIN
Manufacturer
AB BIODISK
Date Cleared
1998-05-29

(121 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

For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This application is for MIC determination of Vancomycin in the range of 0.016 - 256 µg/ml with Streptococcus spp.

Previously cleared applications include non-fastidious Gram positive aerobic bacteria and S. pneumoniae.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Etest® Vancomycin, not a study report detailing acceptance criteria and performance data. Therefore, it does not contain the requested information regarding specific acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study results.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. The "Indications For Use" section provides information on what the device is intended for, but not how its performance was evaluated against specific criteria.

§ 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).