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MicroStrep Plus Panel, Levofloxacin

by Dade Microscan, Inc. 510(k)

Active United States

510(k) K983943

Overview

The MicroStrep Plus Panel, Levofloxacin is a Manual Antimicrobial Susceptibility Test System (product code JWY) designed for in vitro determination of bacterial susceptibility to levofloxacin. It is intended for use in microbiology laboratories to assess microbial resistance patterns, aiding in the selection of appropriate antimicrobial therapy for bacterial infections.

This panel is supplied as a manual test system for use in clinical microbiology settings and has received FDA 510(k) clearance under the Traditional pathway. It is classified as a Class II device under special controls and is intended for single-use. The device is regulated under the Medical Specialty Description of Microbiology and falls under the regulation number 866.1640. No sterility or MRI safety information is specified in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983943 Date18 Feb 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the MicroStrep Plus Panel, Levofloxacin used for in a clinical setting?

    The MicroStrep Plus Panel, Levofloxacin is designed for in vitro testing to determine how susceptible bacteria are to the antibiotic levofloxacin. Clinicians use it in microbiology labs to help identify bacterial resistance patterns, which aids in selecting the most effective antimicrobial treatment for infections caused by these bacteria.

  • Is this device intended for single-use or repeated use?

    The MicroStrep Plus Panel, Levofloxacin is explicitly intended for single-use only. This is a standard practice for antimicrobial susceptibility test systems to ensure accuracy and prevent cross-contamination between samples.

  • How is this panel supplied, and where would it be used?

    The panel is supplied as a manual test system for use exclusively in clinical microbiology laboratories. It is not a point-of-care or automated system, meaning it requires manual handling and interpretation by trained laboratory personnel to assess bacterial susceptibility to levofloxacin.

  • What regulatory pathway was followed for FDA clearance of this device?

    The MicroStrep Plus Panel, Levofloxacin received FDA clearance under the Traditional 510(k) pathway, with a decision described as *Substantially Equivalent* to a predicate device. It is classified as a Class II device under special controls and falls under the regulation number 866.1640 for microbiology-related products.

  • Are there any special storage requirements mentioned for this panel?

    The provided data does not specify any special storage conditions (e.g., temperature, humidity) for the MicroStrep Plus Panel, Levofloxacin. However, as with most diagnostic test systems, it should be stored according to the manufacturer’s instructions (likely in a dry, controlled environment) to maintain integrity until use.