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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 for determining the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus and Streptococcus pneumoniae. It is primarily used by microbiologists and infectious disease specialists in laboratory settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K012565 ↗
Decision Date ?
September 12, 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 September 12, 2001. Manufactured by Trek Diagnostic Systems, it is classified as a Class 2 device under product code JWY.
What It Is
The Sensititre Haemophilus Streptococcus Pneumoniae HP MIC Plate is an in vitro diagnostic device designed to assess the susceptibility of Haemophilus and Streptococcus pneumoniae strains to various antibiotics. It works by exposing bacteria to different concentrations of antibiotics on a microdilution plate, allowing clinicians to determine the MIC, which is crucial for guiding effective antibiotic therapy. This device aids in optimizing treatment regimens and combating antibiotic resistance.
FDA-Cleared Indications
- For in vitro determination of the antimicrobial susceptibility of Haemophilus species.
- For in vitro determination of the antimicrobial susceptibility of Streptococcus pneumoniae.
- For determining minimum inhibitory concentrations using standardized antibiotic concentrations on a microdilution plate.
Clinical Applications
- Testing Haemophilus isolates recovered from clinical specimens for susceptibility to labeled antimicrobial agents.
- Testing Streptococcus pneumoniae isolates recovered from clinical specimens for susceptibility to labeled antimicrobial agents.
- Generating minimum inhibitory concentration results for use with laboratory antimicrobial susceptibility interpretations.
- Supporting selection or adjustment of antimicrobial therapy when interpreted with the organism, specimen, patient condition, and current clinical guidelines.
Practical Considerations
- Use only with the organisms, antimicrobial agents, inoculum preparation, incubation conditions, and interpretation criteria specified in the current manufacturer instructions and applicable standards.
- The plate is intended for trained laboratory personnel and must be used with validated laboratory procedures and compatible equipment.
- Results are in vitro susceptibility findings; they do not independently diagnose infection or guarantee clinical treatment success.
- Interpretation should account for current FDA-recognized or standards-based breakpoints, quality-control requirements, and possible resistance mechanisms.
- This is a laboratory plate, not an implant or imaging device; MRI compatibility, vascular access, anesthesia, and patient anatomical contraindications do not apply.
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 for determining the minimum inhibitory concentration of antibiotics against Haemophilus and Streptococcus pneumoniae.
What specialties typically use this device?
Microbiology and infectious disease specialists in clinical laboratory settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for determining the antibiotic susceptibility of Haemophilus and Streptococcus pneumoniae to guide effective treatment.
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.