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modification to sensititre haemophilus streptococcus pneumoniae hp mic plate
Trek Diagnostic Systems
Summary: The Sensititre 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 infectious disease specialists in clinical laboratories.
FDA Clearance Information
Pathway
510K
Number
K062839 ↗
Decision Date
November 9, 2006
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on November 9, 2006. Manufactured by Trek Diagnostic Systems, it is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Plate is a specialized diagnostic plate used to assess the susceptibility of Haemophilus and Streptococcus pneumoniae to various antibiotics. It works by exposing the bacteria to different concentrations of antibiotics and determining the minimum concentration that inhibits bacterial growth. This is crucial for guiding effective antibiotic therapy.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to perform antibiotic susceptibility testing. It is particularly useful in settings where rapid and accurate determination of antibiotic resistance is essential, such as in hospitals dealing with severe respiratory infections. Infectious disease specialists rely on these results to tailor antibiotic regimens for patients with infections caused by Haemophilus and Streptococcus pneumoniae.
Indications for Use
The FDA-cleared indications allow this device to be used for determining the antibiotic susceptibility of Haemophilus and Streptococcus pneumoniae. This is essential for treating infections caused by these bacteria, ensuring that patients receive the most effective antibiotic therapy.
Practical Considerations
The plates are typically compatible with standard laboratory equipment used for MIC testing. Users should ensure proper storage conditions and handle the plates with care to avoid contamination. The results should be interpreted by qualified personnel to ensure accurate clinical decision-making.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Plate used for?
It is used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus and Streptococcus pneumoniae, guiding effective antibiotic therapy.
What specialties typically use this device?
Microbiologists and infectious disease specialists in clinical laboratories typically use this device.
What are the FDA-cleared indications?
The device is indicated for determining the 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.