SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN

• K Number: K983309
• Device Name: SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
• Manufacturer: ACCUMED INTL., INC.
• Date Cleared: 1998-12-14 ( 84 days)
• Product Code: LTT
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Levofloxacin in the dilution range of 0.004 - 8 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates.

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for a susceptibility testing device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.

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).