Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

• K Number: K230935
• Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
• Manufacturer: Thermo Fisher Scientific
• Date Cleared: 2023-06-30 ( 88 days)
• Product Code: JWY , LRG , LTT
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml for testing fastidious Haemophilus influenzae on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptoccus pneumoniae MIC or Breakpoint Susceptibility System.

Imipenem-relebactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Haemophilus influenzae

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam". This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically focusing on Imipenem-relebactam for Haemophilus influenzae.

However, the provided document is a regulatory approval letter and indications for use statement. It does not contain any information regarding the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your specific questions about the device's performance and the study that proves it meets acceptance criteria.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed test report.

Therefore, I cannot provide the requested table or information regarding the study.

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).