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the sensititre 20 - 24 hour haemophilus influenzae streptococcus pneumoniae hp mic or breakpoint susceptibility system with ceftriaxone in the dilution range of 0 015 - 2 ug ml
Thermo Fisher Scientific
Summary: The Sensititre 20-24 Hour System is used for susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae. Key evidence includes studies on antimicrobial resistance and device accuracy.
FDA Clearance Information
Pathway
510K
Number
K241967 ↗
Decision Date
October 1, 2024
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre 20-24 Hour System by Thermo Fisher Scientific was cleared through the FDA 510k pathway on October 1, 2024. It is classified as a Class 2 device.
What It Is
The Sensititre 20-24 Hour System is a susceptibility testing device designed to determine the minimum inhibitory concentration (MIC) of antibiotics, including ceftriaxone, for Haemophilus influenzae and Streptococcus pneumoniae. It aids clinicians in selecting appropriate antimicrobial therapy.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to guide treatment decisions for infections caused by Haemophilus influenzae and Streptococcus pneumoniae, particularly in cases of suspected antimicrobial resistance.
Evidence Summary
The available literature includes 11 studies, with a mix of RCTs, prospective, and retrospective studies, conducted between 2018 and 2025. These studies focus on antimicrobial resistance patterns and device performance.
Reported Outcomes
Published studies report that the Sensititre system provides accurate susceptibility results for various pathogens, with high concordance rates compared to reference methods. It has been effective in identifying resistance patterns in clinical isolates.
Safety Profile
Reported complications include potential discrepancies in MIC values when compared to other testing methods, though these are rare. No significant adverse events directly related to the device have been documented.
Evidence Limitations
Current evidence is limited by the variability in study designs and the focus on specific geographic regions. Further research is needed to validate findings 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 Sensititre 20-24 Hour System?
The device is indicated for susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae to guide antimicrobial therapy.
What outcomes have been reported in clinical studies?
Studies have shown high accuracy in susceptibility testing and effective identification of resistance patterns.
What complications have been reported?
Safety data indicate rare discrepancies in MIC values compared to other methods, with no significant adverse events reported.
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.