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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 of antibiotics for specific pathogens. It is primarily used by microbiologists and infectious disease specialists.

FDA Clearance Information

Pathway 510K
Decision Date November 20, 2001
Product Code LTT
Device Class Class 2
Evidence 419 studies

This device was cleared through the FDA 510(k) pathway on November 20, 2001. It is manufactured by Trek Diagnostic Systems and classified as a Class 2 device.

What It Is

The Haemophilus Streptococcus Pneumoniae HP MIC Plate is a diagnostic device used to assess the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae. It works by exposing these bacteria to varying concentrations of antibiotics to determine the minimum inhibitory concentration (MIC) that effectively inhibits bacterial growth. This information is crucial for guiding appropriate antibiotic therapy.

Clinical Applications

This device is commonly used in clinical microbiology laboratories to aid in the management of bacterial infections, particularly those caused by Haemophilus influenzae and Streptococcus pneumoniae. It is essential in settings where antibiotic resistance is a concern, such as hospitals and clinics treating respiratory infections, meningitis, and other invasive bacterial diseases. The results help clinicians select the most effective antibiotic treatment for individual patients.

Indications for Use

The FDA indications for this device involve its use in determining the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae. It is intended for use in patients with infections caused by these bacteria to help guide antibiotic therapy.

Practical Considerations

The MIC plate is typically compatible with standard laboratory equipment used for bacterial culture and susceptibility testing. It requires careful handling to avoid contamination and ensure accurate results. Clinicians should be familiar with interpreting MIC values and integrating them into clinical decision-making.

Related Literature

The linked study examined the epidemiology of acute bacterial meningitis in adults in France, highlighting the prevalence of pathogens like Streptococcus pneumoniae and Haemophilus influenzae. It found a significant mortality rate, particularly in pneumococcal meningitis, and noted a decrease in antibiotic susceptibility. The study emphasized the impact of vaccination on reducing Haemophilus influenzae cases. Limitations include its focus on a specific geographic region and time period.

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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Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

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Frequently Asked Questions

What is Haemophilus Streptococcus Pneumoniae HP MIC Plate used for?

It is used to determine the minimum inhibitory concentration of antibiotics for Haemophilus influenzae and Streptococcus pneumoniae, aiding in the selection of effective antibiotic therapy.

What specialties typically use this device?

Microbiologists and infectious disease specialists, particularly those working in clinical microbiology laboratories and hospitals.

What are the FDA-cleared indications?

The device is indicated for determining antibiotic susceptibility of Haemophilus influenzae 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.

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