đź“‹ FDA Reference
sensititre haemophilus streptococcus pneumoniae hp susceptibility plates
Thermo Fisher Scientific
Summary: The Sensititre Haemophilus Streptococcus Pneumoniae HP Susceptibility Plates are used to determine the antibiotic susceptibility of bacterial pathogens. They are primarily used by microbiologists and infectious disease specialists in laboratory settings.
FDA Clearance Information
Pathway
510K
Number
K133847 ↗
Decision Date
August 1, 2014
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The Sensititre HP Susceptibility Plates by Thermo Fisher Scientific were cleared through the FDA 510k pathway on August 1, 2014. 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 to assess the sensitivity of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics. These plates contain predefined concentrations of antibiotics and are used in clinical microbiology labs to guide effective treatment plans. By providing a visual readout of bacterial growth, clinicians can determine which antibiotics are most effective against specific bacterial strains.
Clinical Applications
These susceptibility plates are commonly used in hospital and reference laboratories, particularly in the microbiology department. They are essential in the management of infections caused by Haemophilus influenzae and Streptococcus pneumoniae, especially in patients with respiratory infections, meningitis, or sepsis. Infectious disease specialists and clinical microbiologists rely on these plates to tailor antibiotic therapy for both adult and pediatric patient populations.
Indications for Use
The FDA indications for this device involve testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics. This is crucial for patients with infections caused by these bacteria, allowing for targeted and effective antibiotic treatment.
Practical Considerations
The plates are typically compatible with standard laboratory equipment used for bacterial culture and antibiotic susceptibility testing. Proper technique in inoculating and reading the plates is essential for accurate results. Regular calibration and maintenance of laboratory equipment are recommended to ensure reliability.
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 test the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae.
What specialties typically use this device?
Microbiology and infectious disease specialists in laboratory settings.
What are the FDA-cleared indications?
For determining the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae.
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.