📋 FDA Reference
Sensititre Haemophilus Streptococcus Pneumoniae HP Susceptibility Plates
Thermo Fisher Scientific
Summary: The Sensititre Haemophilus Streptococcus Pneumoniae HP Susceptibility Plates are used for determining antibiotic susceptibility of bacterial strains. They are primarily used by microbiologists and infectious disease specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140985 ↗
Decision Date ?
June 10, 2014
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The Sensititre HP Susceptibility Plates were cleared through the FDA 510k pathway on June 10, 2014. Manufactured by Thermo Fisher Scientific, this device is classified as Class 2 under product code JWY.
What It Is
The Sensititre Haemophilus Streptococcus Pneumoniae HP Susceptibility Plates are diagnostic tools used in microbiology laboratories to assess the susceptibility of Haemophilus and Streptococcus pneumoniae strains to various antibiotics. The plates contain pre-dosed antibiotics, allowing for efficient and standardized testing. This aids clinicians in selecting the most effective treatment for bacterial infections.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus species.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae.
- For use with clinical bacterial isolates in a qualified microbiology laboratory.
Clinical Applications
- Determining whether Haemophilus isolates are susceptible, intermediate, or resistant to selected antibiotics.
- Determining the antimicrobial susceptibility of Streptococcus pneumoniae isolates.
- Generating susceptibility results to support antibiotic treatment decisions for confirmed bacterial infections.
- Monitoring antimicrobial resistance patterns in clinical microbiology laboratories.
Practical Considerations
- These are in vitro laboratory plates, not devices implanted in or used directly on a patient.
- Testing must follow the manufacturer's instructions, applicable laboratory standards, and validated organism identification and inoculum procedures.
- Plates contain specific pre-dosed antimicrobial agents; the available antibiotics and concentration ranges depend on the particular plate configuration.
- Proper storage, handling, incubation, and result interpretation are required to preserve antibiotic activity and produce reliable results.
- MRI compatibility, implant sizing, and vessel or tissue contraindications do not apply because the plates are not used in the body.
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 Sensititre HP Susceptibility Plates used for?
They are used to determine the antibiotic susceptibility of Haemophilus and Streptococcus pneumoniae strains.
What specialties typically use this device?
Microbiologists and infectious disease specialists in clinical and research settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus and Streptococcus pneumoniae to antibiotics, aiding in infection management.
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.