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haemophilus streptococcus pneumoniae hp mic plate
Trek Diagnostic Systems
Summary: The Haemophilus Streptococcus Pneumoniae HP MIC Plate is a diagnostic tool used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus and Streptococcus pneumoniae. It is primarily used by microbiologists and clinicians in laboratory settings to guide antibiotic therapy.
FDA Clearance Information
Pathway
510K
Number
K062022 ↗
Decision Date
September 11, 2006
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510k pathway on September 11, 2006. Manufactured by Trek Diagnostic Systems, it is classified as a Class 2 device under product code JWY.
What It Is
The Haemophilus Streptococcus Pneumoniae HP MIC Plate is a diagnostic device used in microbiology to assess the susceptibility of Haemophilus and Streptococcus pneumoniae to various antibiotics. The device works by exposing bacterial cultures to different concentrations of antibiotics, allowing clinicians to determine the minimum inhibitory concentration (MIC) required to inhibit bacterial growth. This information is crucial for selecting the most effective antibiotic treatment for infections caused by these pathogens.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to guide antibiotic therapy for infections such as pneumonia, meningitis, and other invasive diseases caused by Haemophilus and Streptococcus pneumoniae. It is particularly useful in settings where antibiotic resistance is a concern, allowing for tailored treatment plans. Infectious disease specialists, clinical microbiologists, and laboratory technicians are the primary users of this device.
Indications for Use
The FDA indications suggest that this device is intended for use in determining the antibiotic susceptibility of Haemophilus and Streptococcus pneumoniae. It is particularly relevant for patients with infections caused by these bacteria, helping clinicians choose the most effective antibiotic therapy.
Practical Considerations
The device typically comes in a standardized format compatible with laboratory equipment used for MIC testing. It is important to follow the manufacturer's guidelines for incubation times and conditions to ensure accurate results. Compatibility with specific laboratory systems should be verified before use.
Related Literature
The linked study from 2010 examined the epidemiology of acute bacterial meningitis in adults in France, highlighting Streptococcus pneumoniae and Haemophilus influenzae as leading pathogens. It reported a high mortality rate and noted a decrease in antibiotic susceptibility among these bacteria. The study emphasized the impact of vaccination in reducing Haemophilus influenzae cases. Limitations include its focus on a specific population and time frame.
Linked Studies (20)
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Clinical progress note: Haemophilus influenzae type b.
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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
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Nature
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Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
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History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Haemophilus Streptococcus Pneumoniae HP MIC Plate used for?
It is used to determine the minimum inhibitory concentration of antibiotics against Haemophilus and Streptococcus pneumoniae, guiding effective antibiotic therapy.
What specialties typically use this device?
Infectious disease specialists, clinical microbiologists, and laboratory technicians typically use this device in microbiology laboratories.
What are the FDA-cleared indications?
The device is indicated for determining antibiotic susceptibility of Haemophilus and Streptococcus pneumoniae to guide treatment decisions.
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.