Microscan Dried Gram-positive Mic/Combo Panels With Daptomycin (0.03 - 16 Mcg/Ml)

• • Terminated Z-0720-2021 FDA Class II ·initiated 2 Dec 2020

  Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

510(k) Number

K043545 ↗

FDA Product Code

LRG

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the purpose of the Microscan Dried Gram-positive Mic/Combo Panels with Daptomycin?

  These are in vitro diagnostic devices used for antimicrobial susceptibility testing of gram-positive bacteria. They contain dried antimicrobial agents including daptomycin to determine the minimum inhibitory concentration (MIC) of various antimicrobials, helping clinicians select appropriate antimicrobial therapy for patients with gram-positive bacterial infections.

• How are the Microscan Dried Gram-positive Mic/Combo Panels supplied and used?

  The panels are supplied as single-use products for microbiology laboratories. They are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 environment and can be read either visually or with MicroScan instrumentation to determine antimicrobial susceptibility.

• What regulatory status does the Microscan Dried Gram-positive Mic/Combo Panels with Daptomycin have?

  The device has FDA 510(k) clearance K043545 and is classified under product code LRG. It is cleared as substantially equivalent to predicate devices for antimicrobial susceptibility testing of gram-positive bacteria in microbiology laboratories.

• What is the concentration range of daptomycin in these panels?

  The panels contain daptomycin at concentrations ranging from 0.03 to 16 mcg/ml, which allows for determination of the minimum inhibitory concentration (MIC) of daptomycin against gram-positive bacteria to guide appropriate antimicrobial therapy selection.