Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml

• K Number: K193538
• Device Name: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml
• Manufacturer: Thermo Fisher Scientific
• Date Cleared: 2020-03-12 ( 83 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

This document is a 510(k) clearance letter from the FDA for a specific medical device, Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol, made by Thermo Fisher Scientific. It does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.

FDA clearance letters like this one confirm that the device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. However, the scientific evidence and performance data supporting this determination are part of the original 510(k) submission, which is not fully disclosed in this letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document confirms the clearance of the device but does not detail the specific performance metrics, study design, or ground truth establishment.

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).