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The Sensititre 20-24 Hour Haemophilus Influenzae Streptococcus Pneumoniae HP Mic or Breakpoint Susceptibility System with Linezolid in the Dilution Range of 0 12-32 Ug Ml
Thermo Fisher Scientific
Summary: The Sensititre 20-24 Hour System is used for antimicrobial susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae, including linezolid susceptibility. It is primarily used by microbiologists and infectious disease specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242905 ↗
Decision Date ?
February 10, 2025
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The Sensititre 20-24 Hour System by Thermo Fisher Scientific was cleared through the FDA 510k pathway on February 10, 2025. It is a Class 2 device under product code JWY.
What It Is
The Sensititre 20-24 Hour System is a diagnostic tool designed to determine the minimum inhibitory concentration (MIC) of antibiotics, including linezolid, against Haemophilus influenzae and Streptococcus pneumoniae. It operates by exposing bacterial isolates to a range of antibiotic concentrations and observing growth inhibition. This system aids in selecting appropriate antimicrobial therapy by providing precise susceptibility data.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus influenzae.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae.
- For determining linezolid susceptibility using a dilution range of 0.12-32 µg/mL.
- For use by trained personnel in clinical microbiology laboratories according to the manufacturer's instructions.
Clinical Applications
- Measuring linezolid minimum inhibitory concentrations for Haemophilus influenzae isolates.
- Measuring linezolid minimum inhibitory concentrations for Streptococcus pneumoniae isolates.
- Reporting susceptibility results to support antimicrobial treatment decisions.
- Testing clinical bacterial isolates in a qualified microbiology laboratory.
Practical Considerations
- This is an in vitro laboratory system, not an implantable or patient-contact device.
- Testing requires a properly identified clinical isolate and trained laboratory personnel.
- The labeled linezolid dilution range is 0.12-32 µg/mL; results must be interpreted using current laboratory standards and the manufacturer's instructions.
- The system is not an MRI device and has no MRI safety designation because it is used outside the patient.
- Quality control, appropriate incubation, equipment compatibility, and routine laboratory maintenance are required for reliable 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 20-24 Hour System used for?
It is used for determining the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae, specifically for linezolid.
What specialties typically use this device?
Microbiology laboratories and infectious disease specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to linezolid.
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.