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sensititre 20-24 hour haemophilus influenzaelstreptococcus pneumoniae mic or breakpoint susceptibility system with ceftolozane-tazobactam in the dilution range of 0 03 4-64 4ug ml
Thermo Fisher Scientific
Summary: The Sensititre MIC System by Thermo Fisher Scientific is used for antimicrobial susceptibility testing, specifically for Haemophilus influenzae and Streptococcus pneumoniae. It is commonly used by microbiologists and infectious disease specialists.
FDA Clearance Information
Pathway
510K
Number
K232310 ↗
Decision Date
October 31, 2023
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre MIC System was cleared through the FDA 510(k) pathway on October 31, 2023. Manufactured by Thermo Fisher Scientific, it is a Class 2 device.
What It Is
The Sensititre 20-24 hour MIC System is a diagnostic tool designed to determine the minimum inhibitory concentration (MIC) of antibiotics against specific bacteria, namely Haemophilus influenzae and Streptococcus pneumoniae. It includes ceftolozane-tazobactam in its testing range, allowing for precise measurement of bacterial resistance. This system aids clinicians in selecting appropriate antibiotic therapies by providing detailed susceptibility profiles.
Clinical Applications
This device is primarily used in clinical microbiology laboratories to guide treatment decisions in patients with infections caused by Haemophilus influenzae and Streptococcus pneumoniae. It is particularly useful in hospital settings where rapid and accurate antimicrobial susceptibility testing is critical. Infectious disease specialists and clinical microbiologists rely on this system to tailor antibiotic regimens for patients with respiratory tract infections and other invasive diseases.
Indications for Use
The FDA indications for this device include testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics, including ceftolozane-tazobactam. It is intended for use in identifying effective treatments for infections caused by these bacteria.
Practical Considerations
The Sensititre system is compatible with standard laboratory equipment and requires careful handling to ensure accurate results. It is important to follow the manufacturer's guidelines for dilution ranges and incubation times to achieve reliable MIC readings.
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
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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
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 MIC System used for?
It is used for determining the antimicrobial susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics.
What specialties typically use this device?
Microbiologists and infectious disease specialists in hospital laboratories typically use this device.
What are the FDA-cleared indications?
The device is cleared for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, including ceftolozane-tazobactam.
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.