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the sensititre 20-24 hour haemophilus influenzae streptococcus pneumoniae hp mic or breakpoint susceptibility system with penicillin in the dilution range of 0 015-32 ug ml
Thermo Fisher Scientific
Summary: The Sensititre 20-24 Hour MIC System is a diagnostic tool used to determine the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to penicillin. It is primarily used by microbiologists and infectious disease specialists in clinical laboratories.
FDA Clearance Information
Pathway
510K
Number
K243201 ↗
Decision Date
February 10, 2025
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre MIC System by Thermo Fisher Scientific was cleared via the FDA 510(k) pathway on February 10, 2025. It is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre 20-24 Hour MIC System is an in vitro diagnostic device designed to assess the minimum inhibitory concentration (MIC) of penicillin against Haemophilus influenzae and Streptococcus pneumoniae. It operates by exposing bacterial isolates to a range of penicillin concentrations, from 0.015 to 32 µg/mL, to determine the lowest concentration that inhibits bacterial growth. This information is crucial for guiding appropriate antibiotic therapy.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to support the management of bacterial infections, particularly in patients with respiratory tract infections caused by Haemophilus influenzae or Streptococcus pneumoniae. It aids infectious disease specialists and clinical pharmacists in selecting effective antibiotic regimens, especially in hospital settings where antibiotic resistance is a concern.
Indications for Use
The device is indicated for use in determining the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to penicillin. This is particularly relevant for patients with infections caused by these bacteria, such as pneumonia or meningitis, to ensure effective treatment.
Practical Considerations
The system requires bacterial isolates from clinical specimens and is compatible with standard laboratory equipment. It is important to ensure proper calibration and maintenance of the system for accurate results. The device's range of penicillin concentrations allows for detailed susceptibility profiling.
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
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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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 to determine the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to penicillin, guiding antibiotic therapy decisions.
What specialties typically use this device?
Microbiologists and infectious disease specialists in clinical laboratories commonly use this device.
What are the FDA-cleared indications?
The device is indicated for assessing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to penicillin.
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.