📋 FDA Reference
Sensititre 20-24 Hour Haemophilus Influenzae Streptococcus Pneumoniae Mic or Breakpoint Susceptibility System with Omadacycline in the Dilution Range of 0 008 - 32 Ug Ml
Thermo Fisher Scientific
Summary: The Sensititre MIC System is a diagnostic tool used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae. It is primarily used by microbiologists and clinicians in hospital laboratories.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K183324 ↗
Decision Date ?
February 15, 2019
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The Sensititre MIC System was cleared through the FDA 510(k) pathway on February 15, 2019. Manufactured by Thermo Fisher Scientific, it is classified as a Class 2 device.
What It Is
The Sensititre 20-24 Hour MIC System is a laboratory diagnostic device designed to assess the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, including omadacycline. It operates by determining the minimum inhibitory concentration (MIC) of antibiotics, which helps guide appropriate antimicrobial therapy. The system uses a range of dilutions from 0.008 to 32 µg/ml to provide precise susceptibility results.
FDA-Cleared Indications
- For in vitro susceptibility testing of Haemophilus influenzae to antimicrobial agents.
- For in vitro susceptibility testing of Streptococcus pneumoniae to antimicrobial agents.
- The system includes omadacycline in a dilution range of 0.008 to 32 µg/mL.
Clinical Applications
- Determining the minimum inhibitory concentration of antimicrobial agents against Haemophilus influenzae in a clinical microbiology laboratory.
- Determining the minimum inhibitory concentration of antimicrobial agents against Streptococcus pneumoniae in a clinical microbiology laboratory.
- Performing antimicrobial susceptibility testing when these organisms are recovered from patient specimens.
- Generating susceptibility results to support interpretation of antimicrobial activity according to applicable laboratory standards and labeling.
Practical Considerations
- This is an in vitro laboratory system, not an implantable or therapeutic device, and it is used by trained laboratory personnel.
- Testing requires appropriate organism identification, inoculum preparation, incubation, quality control, and interpretation according to the product instructions and current laboratory standards.
- The reported result is an MIC or breakpoint susceptibility result; it does not by itself determine the antibiotic, dose, or duration of treatment.
- The device is not intended for direct patient use and has no MRI safety classification or imaging compatibility indication.
- The antimicrobial dilution range for omadacycline is 0.008 to 32 µg/mL; results outside the available range may require additional testing or a different method.
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 typically use this device.
What are the FDA-cleared indications?
It is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics.
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.