MicroScan Rapid Fluorogenic Panels

• 2 recalls, same reason

  • Terminated Z-0170-2015 FDA Class I ·initiated 17 Oct 2014
  • Terminated Z-0171-2015 FDA Class I ·initiated 17 Oct 2014

  An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.

• • Terminated Z-0668-05 FDA Unclassified (pre-2012) ·initiated 7 Feb 2005

  There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

Trade Name

Microscan Rapid Panels

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

P870049 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APRL

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• What is the primary purpose of the MicroScan Rapid Fluorogenic Panels in a clinical setting?

  The MicroScan Rapid Fluorogenic Panels are designed to automate the detection of antimicrobial resistance in bacterial isolates, allowing clinical microbiology laboratories to quickly identify effective treatment options. By generating a fluorogenic signal during incubation, the system accelerates the process of determining susceptibility to antibiotics, helping clinicians make faster, data-driven decisions.

• Are the MicroScan Rapid Fluorogenic Panels intended for single-use or repeated use?

  These panels are explicitly supplied as single-use, sterile consumables. This design ensures consistency in results and reduces the risk of cross-contamination between tests, which is critical in microbiological testing where accuracy and reliability are paramount.

• How are the MicroScan Rapid Fluorogenic Panels integrated into a clinical workflow?

  The panels are intended for use within automated microbiology workstations, streamlining the process of antimicrobial susceptibility testing. Their short-incubation design allows for faster results compared to traditional methods, fitting seamlessly into high-volume laboratory environments where efficiency is key.

• What regulatory pathway was followed for the approval of the MicroScan Rapid Fluorogenic Panels?

  The device was authorized through the FDA’s Premarket Approval (PMA) process, with PMA number P870049. This pathway is typically used for higher-risk medical devices, ensuring that the system meets stringent performance and safety standards before clinical use. The approval reflects compliance with FDA regulations under 866.1645 for automated antimicrobial susceptibility testing systems.

• Do the MicroScan Rapid Fluorogenic Panels require any special handling or storage conditions?

  While the device data does not specify exact storage conditions, as single-use sterile consumables, they should be stored in a clean, dry environment protected from contamination and extreme temperatures. Proper storage ensures sterility and maintains the integrity of the panels until use, adhering to standard microbiological laboratory practices.