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sensititre 20-24 hour haemophilus influenzae streptococcus pneumoniae mic or breakpoint susceptibility system with dtest containing erythromycin at 1 ug ml and clindamycin at 0 5 ug ml
Thermo Fisher Scientific
Summary: The Sensititre 20-24 hour MIC system is used for determining the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics. It's primarily used by microbiologists and clinicians in infectious disease settings.
FDA Clearance Information
Pathway
510K
Number
K202612 ↗
Decision Date
July 23, 2021
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre MIC system by Thermo Fisher Scientific was cleared via the FDA 510k pathway on July 23, 2021. It is a Class 2 device under product code JWY.
What It Is
The Sensititre 20-24 hour MIC system is a diagnostic tool designed to assess the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It includes a D-test to detect inducible clindamycin resistance. This system helps clinicians make informed decisions about antibiotic therapy by providing precise susceptibility data.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to guide antibiotic therapy for respiratory infections caused by Haemophilus influenzae and Streptococcus pneumoniae. It is particularly relevant in hospital settings where rapid and accurate antibiotic susceptibility testing is crucial for managing infections in patients with compromised immune systems or chronic respiratory conditions.
Indications for Use
The FDA-cleared indications for this device involve testing the susceptibility of specific bacteria to antibiotics, helping clinicians choose effective treatments for infections caused by Haemophilus influenzae and Streptococcus pneumoniae.
Practical Considerations
The system requires standard laboratory equipment for setup and operation. It is compatible with various clinical specimens and provides results within 20-24 hours. Proper training in microbiological techniques is essential for accurate interpretation of results.
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 antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae.
What specialties typically use this device?
Microbiologists and infectious disease specialists in hospital laboratories commonly use this device.
What are the FDA-cleared indications?
It is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, aiding in the selection of appropriate antimicrobial therapy.
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.