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sensititre haemophilus streptococcus pneumoniae mic plate
Accumed Intl.
Summary: The Sensititre Haemophilus Streptococcus Pneumoniae MIC Plate is a diagnostic device used to determine the minimum inhibitory concentration (MIC) of antibiotics against specific bacteria. It is typically used by microbiologists and clinicians in laboratory settings to guide antimicrobial therapy.
FDA Clearance Information
Pathway
510K
Number
K965190 ↗
Decision Date
March 19, 1997
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on March 19, 1997. Manufactured by Accumed Intl., it is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre Haemophilus Streptococcus Pneumoniae MIC Plate is a diagnostic tool designed to assess the susceptibility of bacteria, specifically Haemophilus influenzae and Streptococcus pneumoniae, to various antibiotics. It works by incorporating microbroth dilution techniques to determine the minimum inhibitory concentration (MIC) of antimicrobials, which helps in selecting appropriate antibiotic therapy. This device is crucial in clinical microbiology for optimizing patient treatment plans.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to test the antibiotic susceptibility of bacterial isolates from patients with respiratory infections. It is particularly useful in settings where rapid and accurate determination of bacterial resistance is critical, such as hospitals and research institutions. The primary users are clinical microbiologists and infectious disease specialists who manage patients with community-acquired respiratory infections.
Indications for Use
The FDA indications suggest that this device is used for determining the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae. It is intended for patients with infections caused by these bacteria, aiding in the selection of effective antimicrobial therapy.
Practical Considerations
The Sensititre MIC Plate is compatible with standard laboratory equipment used for microbroth dilution techniques. It is important to follow the manufacturer's instructions for use to ensure accurate results. The plates are typically available in standardized formats to facilitate ease of use in various laboratory settings.
Related Literature
The linked study, part of the Alexander Project, investigated the antimicrobial susceptibility of community-acquired lower respiratory tract pathogens across multiple centers in the EU and USA. Using the Sensititre microbroth technique, it analyzed 6385 isolates, highlighting the prevalence of Haemophilus influenzae and Streptococcus pneumoniae. The study provided valuable insights into the resistance patterns of these pathogens, although its limitations include the potential variability in isolate collection and the focus on specific geographic regions.
Linked Studies (20)
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Sensititre Haemophilus Streptococcus Pneumoniae MIC Plate used for?
It is used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae to guide effective antimicrobial therapy.
What specialties typically use this device?
Clinical microbiologists and infectious disease specialists primarily use this device in laboratory settings to manage bacterial infections.
What are the FDA-cleared indications?
The device is indicated for assessing the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae, aiding in the selection of appropriate antimicrobial treatments.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.