Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL

• K Number: K172454
• Device Name: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
• Manufacturer: Thermo Fisher Scientific
• Date Cleared: 2017-10-13 ( 60 days)
• Product Code: JWY , LRG , LTT
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

The provided documents (K172454) are a 510(k) clearance letter for an antimicrobial susceptibility test system. They do not contain the detailed study information required to answer the questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement. The documents are a formal communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, but they do not disclose the specifics of the performance studies or the data used for that determination.

Therefore, I cannot provide the requested information based on the given input.

Regulation Number and Section

§ 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).