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Sensititre Haemophilus Streptococcus Pneumoniae HP Mic Plate
Trek Diagnostic Systems
Summary: The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Plate 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 laboratory settings to guide antibiotic therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K012921 ↗
Decision Date ?
November 2, 2001
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Plate was cleared through the FDA 510(k) pathway on November 2, 2001. It is manufactured by Trek Diagnostic Systems and is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Plate is a diagnostic tool designed to assess the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to various antibiotics. It works by exposing bacterial isolates to a range of antibiotic concentrations and determining the minimum concentration that inhibits bacterial growth. This information is crucial for selecting effective antibiotic treatments and combating antibiotic resistance.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus influenzae isolates.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae isolates.
- For determining MIC values for the antimicrobial agents included on the plate.
Clinical Applications
- Testing Haemophilus influenzae isolates recovered from clinical specimens.
- Testing Streptococcus pneumoniae isolates recovered from clinical specimens.
- Determining antibiotic MIC values in a clinical microbiology laboratory.
- Supporting selection of antimicrobial therapy when interpreted with the patient’s clinical findings and applicable laboratory standards.
Practical Considerations
- The plate is intended for trained laboratory personnel and must be used with the applicable inoculation, incubation, reading and interpretation procedures.
- Results depend on a viable, correctly identified bacterial isolate and appropriate preparation of the test inoculum.
- Only antibiotics and concentration ranges included on the specific plate should be reported according to the device labeling and current laboratory standards.
- Plates require appropriate storage, handling and quality control; expired, damaged or improperly stored plates may produce unreliable results.
- This is an in vitro diagnostic device, not an implant or therapeutic device. It is not evaluated for MRI safety and has no patient-contact use.
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 Haemophilus Streptococcus Pneumoniae HP MIC Plate used for?
It is used to determine the minimum inhibitory concentration of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae to guide effective antibiotic therapy.
What specialties typically use this device?
Clinical microbiologists, infectious disease specialists, and pharmacists typically use this device in laboratory and hospital settings.
What are the FDA-cleared indications?
The device is indicated for testing the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to antibiotics, helping to identify effective treatments for infections caused by these bacteria.
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.