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the sensititre 20 - 24 hour haemophilus influenzae streptococcus pneumoniae hp mic or breakpoint susceptibility system with meropenem in the dilution range of 0 015 - 32 ug ml
Thermo Fisher Scientific
Summary: The Sensititre 20-24 Hour System is a susceptibility testing device for Haemophilus influenzae and Streptococcus pneumoniae. It is primarily used to determine MIC or breakpoint susceptibility with meropenem. Key evidence includes studies on antimicrobial resistance and testing accuracy.
FDA Clearance Information
Pathway
510K
Number
K242021 ↗
Decision Date
October 9, 2024
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on October 9, 2024. It is manufactured by Thermo Fisher Scientific and classified as a Class 2 device under product code JWY.
What It Is
The Sensititre 20-24 Hour System is a diagnostic tool designed to assess the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, specifically using meropenem in a dilution range of 0.015 - 32 µg/mL. It aids clinicians in determining 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 where antibiotic resistance is a concern.
Evidence Summary
The available literature includes 11 studies, with a mix of RCTs, prospective, retrospective, and case series designs. These studies span from 2024 to 2025 and focus on antimicrobial resistance and susceptibility testing accuracy.
Reported Outcomes
Published studies report that the Sensititre system provides accurate susceptibility testing results, with high concordance rates compared to reference methods. It has been shown to effectively identify resistance patterns in multidrug-resistant strains, aiding in the selection of effective treatments.
Safety Profile
Reported complications include potential discrepancies in susceptibility results due to variations in testing conditions. However, no significant adverse events related to the device's use have been documented in the available studies.
Evidence Limitations
The evidence is limited by the relatively short time frame of the studies and the focus on specific bacterial strains. Further research is needed to validate findings across diverse clinical settings and to explore long-term outcomes.
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 determining the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, particularly in cases of suspected resistance.
What outcomes have been reported in clinical studies?
Studies report high accuracy in susceptibility testing and effective identification of resistance patterns in multidrug-resistant strains.
What complications have been reported?
Safety data indicate potential discrepancies in results due to testing condition variations, but no significant adverse events have been 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.