Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

• K Number: K183033
• Device Name: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
• Manufacturer: Thermo Fisher Scientific
• Date Cleared: 2019-01-04 ( 64 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 for an antimicrobial susceptibility test (AST) system. It does not contain information about acceptance criteria or a study proving that a device meets such criteria because it's a regulatory approval document, not a detailed study report. Therefore, I cannot provide the requested information from this document.

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).