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sensititre haemophilus streptococcus pneumoniae hp mic susceptibility plate and susceptibility test panel
Trek Diagnostic Systems
Summary: The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Susceptibility Plate is a diagnostic tool used to determine the minimum inhibitory concentration (MIC) of antibiotics against specific bacterial strains. It is primarily used by microbiologists and clinicians in laboratory settings.
FDA Clearance Information
Pathway
510K
Number
K041534 ↗
Decision Date
July 27, 2004
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre HP MIC Susceptibility Plate was cleared through the FDA 510(k) pathway on July 27, 2004. Manufactured by Trek Diagnostic Systems, it is classified as a Class 2 device under the product code JWY.
What It Is
The Sensititre HP MIC Susceptibility Plate is a diagnostic device designed to assess the susceptibility of Haemophilus and Streptococcus pneumoniae strains to various antibiotics. It functions by allowing clinicians to determine the minimum inhibitory concentration (MIC) required to inhibit bacterial growth, aiding in the selection of appropriate antimicrobial therapy. This device is crucial in guiding effective treatment plans and combating antibiotic resistance.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to test the susceptibility of bacterial isolates from patient samples. It is particularly relevant in settings where respiratory infections, such as pneumonia, are prevalent, and accurate antibiotic selection is critical. Infectious disease specialists, clinical microbiologists, and laboratory technicians frequently utilize this tool to ensure targeted and effective antimicrobial therapy.
Indications for Use
The FDA-cleared indications for this device involve testing the susceptibility of Haemophilus and Streptococcus pneumoniae to antibiotics. It is used in patients with infections caused by these bacteria, helping clinicians choose the most effective antibiotic treatment.
Practical Considerations
The Sensititre HP MIC Susceptibility Plate is compatible with standard laboratory equipment used for microbial culture and susceptibility testing. It requires careful handling to ensure accurate results, and users should be trained in interpreting MIC values to guide clinical decision-making effectively.
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 HP MIC Susceptibility Plate used for?
It is used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus and Streptococcus pneumoniae, aiding in effective antibiotic selection.
What specialties typically use this device?
Infectious disease specialists, clinical microbiologists, and laboratory technicians in microbiology labs commonly use this device.
What are the FDA-cleared indications?
The device is indicated for testing antibiotic susceptibility of Haemophilus and Streptococcus pneumoniae strains in clinical settings.
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.