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sensititre haemophilus streptococcus pneumoniae hp mic susceptibility plate
Trek Diagnostic Systems
Summary: The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Susceptibility Plate is a diagnostic tool used to determine antibiotic susceptibility in bacterial infections. It is primarily used by microbiologists and infectious disease specialists in clinical laboratories.
FDA Clearance Information
Pathway
510K
Number
K013580 ↗
Decision Date
December 12, 2001
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on December 12, 2001. It is manufactured by Trek Diagnostic Systems and classified as a Class 2 device under product code JWY.
What It Is
The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Susceptibility Plate is a diagnostic device designed to assess the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It works by exposing bacteria to various antibiotics and measuring growth inhibition, helping clinicians choose effective treatments. This plate is part of a broader system used in clinical microbiology laboratories to guide antibiotic therapy decisions.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to test the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae, which are common pathogens in respiratory infections. It is particularly useful in hospitals and clinics where rapid and accurate antibiotic susceptibility testing is crucial for managing infections, especially in patients with pneumonia or other respiratory conditions. Infectious disease specialists and laboratory technicians rely on this tool to tailor antibiotic therapy to individual patient needs.
Indications for Use
The FDA indications for this device involve testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics. It is used in cases where determining the most effective antibiotic treatment is critical, such as in severe respiratory infections.
Practical Considerations
The device is compatible with standard laboratory equipment used for susceptibility testing. It requires careful handling and precise technique to ensure accurate results. Users should be familiar with interpreting MIC values and integrating them into 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
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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
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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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
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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
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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 Susceptibility Plate used for?
It is used to determine the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae, aiding in the selection of effective treatments.
What specialties typically use this device?
This device is primarily used by microbiologists and infectious disease specialists in clinical laboratory settings.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, helping guide treatment decisions in respiratory infections.
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.