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Sensititre 20-24 Hour Haemophilus Influenzae Streptococcus Pneumoniae Mic or Breakpoint Susceptibility System with Lefamulin in the Dilution Range of 0 008-16ug Ml
Thermo Fisher Scientific
Summary: The Sensititre MIC System is a diagnostic device used for determining the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It is primarily used by microbiologists and infectious disease specialists in clinical laboratories.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193024 ↗
Decision Date ?
January 8, 2020
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 January 8, 2020. It is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre MIC System is a diagnostic tool designed to assess the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics, including lefamulin, within a dilution range of 0.008-16 µg/ml. This system aids clinicians in selecting appropriate antimicrobial therapy by providing precise MIC values. It operates by exposing bacterial isolates to serial dilutions of antibiotics and determining the lowest concentration that inhibits visible growth.
FDA-Cleared Indications
- For in vitro susceptibility testing of Haemophilus influenzae isolates to antimicrobial agents included in the system.
- For in vitro susceptibility testing of Streptococcus pneumoniae isolates to antimicrobial agents included in the system.
- For determining minimum inhibitory concentrations or breakpoint susceptibility results using the labeled antimicrobial dilution ranges, including lefamulin at 0.008–16 µg/mL.
Clinical Applications
- Laboratory susceptibility testing of Haemophilus influenzae isolates from clinical specimens.
- Laboratory susceptibility testing of Streptococcus pneumoniae isolates from clinical specimens.
- Determining antimicrobial MIC values to support selection or adjustment of treatment for infections caused by susceptible bacterial isolates.
- Reporting breakpoint-based susceptibility results according to applicable laboratory standards and the product labeling.
Practical Considerations
- This is an in vitro diagnostic system for trained clinical microbiology personnel; it is not implanted or administered to patients.
- Accurate results require correct organism identification, standardized inoculum preparation, appropriate culture conditions, and interpretation according to current laboratory standards and product instructions.
- The system uses predefined antimicrobial concentrations and should not be interpreted outside the labeled dilution range or organism claims.
- It is not an MRI device, and MRI compatibility or patient contraindications do not apply.
- The system requires compatible laboratory equipment, controlled storage and handling, quality-control testing, and appropriate maintenance according to the manufacturer’s instructions.
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 antibiotic selection.
What specialties typically use this device?
Microbiologists and infectious disease specialists in clinical laboratories typically use this device.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, assisting in the treatment of infections caused by these bacteria.
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.