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sensititre 20-24-hour haemophilus influenzae streptococcus pneumoniae mic or breakpoint susceptibility system with delafloxacin in the dilution range of 0 00025-8ug ml streptococcus species and 0 000125-8ug ml haemophilus influenzae
Thermo Fisher Scientific
Summary: The Sensititre MIC System is a diagnostic tool used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It's primarily used by microbiologists and infectious disease specialists.
FDA Clearance Information
Pathway
510K
Number
K223844 ↗
Decision Date
March 21, 2023
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre MIC System was cleared through the FDA 510(k) pathway on March 21, 2023. Manufactured by Thermo Fisher Scientific, it is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre 20-24-hour MIC System is a laboratory diagnostic device designed to assess the susceptibility of bacterial pathogens, specifically Haemophilus influenzae and Streptococcus pneumoniae, to the antibiotic delafloxacin. By providing precise MIC values, it helps clinicians tailor antibiotic therapy to combat bacterial infections effectively. This system operates by exposing bacteria to varying concentrations of the antibiotic and determining the lowest concentration that inhibits visible growth.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to guide antibiotic therapy decisions. It is particularly useful in hospitals and clinics where rapid and accurate antibiotic susceptibility testing is crucial for managing infections caused by Haemophilus influenzae and Streptococcus pneumoniae. Infectious disease specialists and clinical microbiologists rely on this system to optimize treatment regimens for patients with respiratory infections or other conditions caused by these bacteria.
Indications for Use
The FDA-cleared indications for this device include testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to delafloxacin. It is intended for use in clinical settings to aid in the selection of appropriate antibiotic therapy for infections caused by these pathogens.
Practical Considerations
The Sensititre MIC System requires careful handling and precise preparation of bacterial samples to ensure accurate results. It is compatible with standard laboratory equipment and requires trained personnel to interpret the MIC values correctly. The system's design allows for flexibility in testing a range of antibiotic concentrations, making it adaptable to various clinical needs.
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 MIC System used for?
It is used to determine the minimum inhibitory concentration of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae, aiding in the selection of effective antibiotic therapy.
What specialties typically use this device?
The device is primarily used by clinical microbiologists and infectious disease specialists in hospital and laboratory settings.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to the antibiotic delafloxacin.
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.