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ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200512

by Biomerieux Sa

Identifiers

510(k) Number
K200512 FDA 510(k)
FDA Product Code
JWY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1640 FDA 510(k)
Regulation Number
866.1640 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ETEST Plazomicin (PLZ) (0.016–256 µg/mL) is a manual antimicrobial susceptibility test system designed for quantitative determination of bacterial susceptibility to plazomicin. Classified as a manual antimicrobial susceptibility test system, it employs a thin, inert plastic strip with a predefined antibiotic gradient and MIC reading scale to assess minimum inhibitory concentrations (MICs) of non-fastidious and fastidious aerobic bacteria, including Gram-negative and Gram-positive organisms.

This device is supplied as a manual, non-automated test for use in microbiology laboratories. Each strip is single-use and intended for in vitro diagnostic use, with no sterility requirements specified. The test strips are regulated under FDA 510(k) clearance (K200512) and fall under device class II (866.1640). Storage and handling conditions are not detailed in the data but are typically governed by standard microbiological laboratory protocols. The product is distributed under the product code JWY and is intended exclusively for professional use in clinical microbiology settings.

Frequently asked questions

What is the ETEST Plazomicin (PLZ) used for?

The ETEST Plazomicin (PLZ) is designed for quantitative determination of bacterial susceptibility to plazomicin. It measures minimum inhibitory concentrations (MICs) in the range of 0.016–256 µg/mL, helping clinicians assess how effective plazomicin will be against non-fastidious and fastidious aerobic bacteria, including both Gram-negative and Gram-positive organisms. This aids in guiding targeted antibiotic therapy.

How is the ETEST Plazomicin (PLZ) supplied and what are its usage instructions?

The ETEST Plazomicin (PLZ) is supplied as single-use plastic strips with a predefined antibiotic gradient and MIC reading scale. Each strip is intended for manual, in vitro diagnostic use in microbiology laboratories. The strips are not sterile and must be handled according to standard microbiological laboratory protocols. The test is non-automated, requiring manual interpretation of results based on bacterial growth inhibition zones.

Is the ETEST Plazomicin (PLZ) reusable or single-use?

The ETEST Plazomicin (PLZ) strips are explicitly designed for single-use only. Each strip contains a gradient of plazomicin and a MIC scale, which may degrade or become contaminated after use. Reusing strips could compromise accuracy and introduce cross-contamination risks, so adherence to single-use guidelines is critical for reliable testing.

What storage conditions should be followed for the ETEST Plazomicin (PLZ)?

While specific storage conditions are not detailed in the provided data, ETEST strips generally require protection from light, moisture, and extreme temperatures to maintain integrity. They should be stored in a clean, dry environment as per standard microbiological laboratory protocols. Always refer to the manufacturer’s instructions for precise storage guidelines to ensure optimal performance and validity of results.

What regulatory pathway does the ETEST Plazomicin (PLZ) follow?

The ETEST Plazomicin (PLZ) is regulated under the FDA 510(k) clearance pathway, specifically under clearance number K200512. It falls under device class II (866.1640) and was determined to be substantially equivalent to a predicate device through a traditional review process by the Microbiology (MI) Advisory Committee. This classification ensures it meets FDA standards for safety and effectiveness as an antimicrobial susceptibility test system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Product: ETEST PLAZOMICIN PLZ US S30 - 421576 - bioMérieux, ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (K200512) — FDA 510 (k ..., Microbiology Reagent ETEST® Plazomicin (PLZ) CLIA - McKesson, K200512 FDA 510(k) - ETEST Plazomicin (PLZ) (0.016-256 µg/mL), PDF Plazomicin Susceptibility Testing Materials

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomerieux Sa
FDA Applicant
Biomérieux SA

Sources (1)

  • FDA 510(k) K200512 24 fields · synced Oct 5, 2026