SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE

• K Number: K073653
• Device Name: SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
• Manufacturer: TREK DIAGNOSTIC SYSTEMS, INC.
• Date Cleared: 2008-03-20 ( 85 days)
• Product Code: JWY , LRG
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of: "Dtest". The Dtest for Broth Microdilution Test is for Staphylococcus spp. resistant to (MIC's ≥ 8ug/ml) erythromycin and susceptible or intermediate (MIC's

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter for The Sensititre® 18-24 MIC or BP Susceptibility System with Dtest 1 and 2 for Staphylococcus spp. It states that the device is substantially equivalent to legally marketed predicate devices. The document does not contain acceptance criteria for device performance or a study proving it meets these criteria. It provides an "Indications for Use" statement, but no performance data. Therefore, the requested information cannot be extracted 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).