📋 FDA Reference
Sensititre 20-24 Hour Haemophilus Influenzaelstreptococcus Pneumoniae Mic or Breakpoint Susceptibility System with Ceftolozane-Tazobactam in the Dilution Range of 0 03 4-64 4ug Ml
Thermo Fisher Scientific
Summary: The Sensititre MIC System by Thermo Fisher Scientific is used for antimicrobial susceptibility testing, specifically for Haemophilus influenzae and Streptococcus pneumoniae. It is commonly used by microbiologists and infectious disease specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K232310 ↗
Decision Date ?
October 31, 2023
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The Sensititre MIC System was cleared through the FDA 510(k) pathway on October 31, 2023. Manufactured by Thermo Fisher Scientific, it is a Class 2 device.
What It Is
The Sensititre 20-24 hour MIC System is a diagnostic tool designed to determine the minimum inhibitory concentration (MIC) of antibiotics against specific bacteria, namely Haemophilus influenzae and Streptococcus pneumoniae. It includes ceftolozane-tazobactam in its testing range, allowing for precise measurement of bacterial resistance. This system aids clinicians in selecting appropriate antibiotic therapies by providing detailed susceptibility profiles.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus influenzae.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae.
- Provides MIC or breakpoint susceptibility results using specified antimicrobial dilution ranges, including ceftolozane-tazobactam at 0.03/4 to 64/4 µg/mL.
Clinical Applications
- Testing clinical isolates of Haemophilus influenzae in a clinical microbiology laboratory.
- Testing clinical isolates of Streptococcus pneumoniae in a clinical microbiology laboratory.
- Determining minimum inhibitory concentrations for selected antimicrobial agents.
- Producing susceptibility or breakpoint results to support antimicrobial treatment decisions for infections caused by the labeled organisms.
Practical Considerations
- This is an in vitro laboratory system, not an implantable or patient-contact device.
- Use is limited to the labeled organisms, antimicrobial agents, dilution ranges, inoculum preparation, incubation conditions and interpretation criteria.
- Laboratories should follow the manufacturer's instructions and applicable CLSI or other authorized susceptibility-testing standards.
- Results should be interpreted with organism identification, specimen source, clinical findings and current antimicrobial breakpoints; the system does not independently diagnose an infection.
- The device has no MRI-safety designation because it is used outside the patient and is not an implanted or body-contacting device.
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 for determining the antimicrobial susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics.
What specialties typically use this device?
Microbiologists and infectious disease specialists in hospital laboratories typically use this device.
What are the FDA-cleared indications?
The device is cleared for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, including ceftolozane-tazobactam.
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.