📋 FDA Reference
The Sensititre 20-24 Hour Haemophilus Influenzae Streptococcus Pneumoniae HP Mic or Breakpoint Susceptibility System with Ceftobiprole in the Dilution Range of 0 008-16 Ug Ml
Thermo Fisher Scientific
Summary: The Sensititre 20-24 hour system by Thermo Fisher Scientific is used for antimicrobial susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae. It is primarily used by microbiologists and infectious disease specialists to guide antibiotic therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242843 ↗
Decision Date ?
June 20, 2025
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The device was cleared through the FDA 510(k) pathway on June 20, 2025, by Thermo Fisher Scientific. It is a Class 2 device under product code JWY.
What It Is
The Sensititre 20-24 hour system is a diagnostic tool used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It operates by exposing bacterial isolates to a range of ceftobiprole concentrations, helping clinicians assess the susceptibility of these pathogens to the antibiotic. This information is crucial for selecting effective antimicrobial therapy.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus influenzae.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae.
- For testing susceptibility to ceftobiprole using concentrations from 0.008 to 16 µg/mL.
- For use with isolated bacterial organisms in a clinical microbiology laboratory.
Clinical Applications
- Determining ceftobiprole MIC results for Haemophilus influenzae isolates.
- Determining ceftobiprole MIC results for Streptococcus pneumoniae isolates.
- Supporting interpretation of bacterial susceptibility results for antimicrobial treatment decisions.
- Testing clinical bacterial isolates using standardized laboratory dilution and incubation procedures.
Practical Considerations
- This is an in vitro laboratory system, not a device implanted in or applied directly to a patient.
- Testing requires a properly isolated and identified Haemophilus influenzae or Streptococcus pneumoniae strain from a clinical specimen.
- The labeled ceftobiprole dilution range is 0.008 to 16 µg/mL; results should be interpreted according to current laboratory standards and the manufacturer's instructions.
- Accurate results depend on appropriate inoculum preparation, media, incubation conditions, quality control, and reading procedures.
- MRI compatibility and patient contraindications do not apply because the system is used outside the body; laboratory safety and handling requirements do apply.
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 antimicrobial susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae to guide antibiotic therapy.
What specialties typically use this device?
Microbiologists and infectious disease specialists typically use this device in clinical laboratory settings.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to ceftobiprole.
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.