đź“Š Evidence-Based Reference
sensitive haemophilus influenzae streptococcus pneumonia hp mic susceptibility plates
Trek Diagnostic Systems
Summary: The sensitive haemophilus influenzae streptococcus pneumonia hp mic susceptibility plates, manufactured by Trek Diagnostic Systems, are used for determining microbial susceptibility. Key evidence highlights their role in identifying resistance patterns in pathogens like Streptococcus pneumoniae and Haemophilus influenzae.
FDA Clearance Information
Pathway
510K
Number
K093741 ↗
Decision Date
February 25, 2010
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on February 25, 2010. It is manufactured by Trek Diagnostic Systems and classified as a Class 2 device under product code JWY.
What It Is
This device is a diagnostic tool used to assess the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It aids clinicians in determining the susceptibility of these pathogens to various antimicrobial agents.
Clinical Applications
The device is commonly used in clinical microbiology laboratories to guide antibiotic therapy for infections caused by Haemophilus influenzae and Streptococcus pneumoniae. It is particularly useful in cases of community-acquired pneumonia where antibiotic resistance is a concern.
Evidence Summary
The literature includes 15 studies, primarily focusing on the detection and resistance patterns of Streptococcus pneumoniae and Haemophilus influenzae. The studies span from 2022 to 2024 and include various methodologies such as PCR and metagenomic sequencing.
Reported Outcomes
Published studies report that the device effectively identifies antibiotic resistance patterns in Streptococcus pneumoniae and Haemophilus influenzae. The use of the device has been associated with improved detection rates of these pathogens in clinical samples.
Safety Profile
Reported complications include the potential for false negatives or positives due to technical errors in the testing process. However, no significant adverse events directly related to the device's use have been documented.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to validate the device's efficacy across diverse clinical settings and populations.
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 are the clinical indications for sensitive haemophilus influenzae streptococcus pneumonia hp mic susceptibility plates?
The device is indicated for determining the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae in clinical samples.
What outcomes have been reported in clinical studies?
Studies have reported effective identification of antibiotic resistance patterns in the targeted pathogens, aiding in appropriate antibiotic selection.
What complications have been reported?
Safety data indicate potential for technical errors leading to false results, but no significant adverse events have been directly linked to the device.
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.