📋 FDA Reference
Haemophilus Streptococcus Pneumoniae HP Mic Susceptibility Plates
Trek Diagnostic Systems
Summary: The Haemophilus Streptococcus Pneumoniae HP MIC Susceptibility Plates are used to determine the minimum inhibitory concentration (MIC) of antibiotics against specific bacteria. This device is primarily used by microbiologists and infectious disease specialists in laboratory settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013195 ↗
Decision Date ?
November 7, 2001
Product Code ?
LTT
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on November 7, 2001. It is manufactured by Trek Diagnostic Systems and classified as a Class 2 device under product code LTT.
What It Is
The Haemophilus Streptococcus Pneumoniae HP MIC Susceptibility Plates are diagnostic tools used in microbiology to assess the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae. These plates help determine the minimum inhibitory concentration (MIC) of various antibiotics, which is crucial in guiding effective treatment plans for bacterial infections. The device works by exposing bacteria to different concentrations of antibiotics and observing growth inhibition.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus influenzae.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae.
- For determining the minimum inhibitory concentration of selected antimicrobial agents by assessing bacterial growth at different antibiotic concentrations.
Clinical Applications
- Testing clinical isolates of Haemophilus influenzae for susceptibility to selected antibiotics.
- Testing clinical isolates of Streptococcus pneumoniae for susceptibility to selected antibiotics.
- Generating MIC results for antimicrobial susceptibility reports in clinical microbiology laboratories.
- Supporting antibiotic selection for infections caused by susceptible Haemophilus influenzae or Streptococcus pneumoniae isolates.
Practical Considerations
- This is an in vitro diagnostic laboratory product, not an implant or device used directly in a patient.
- Accurate results depend on the correct organism identification, inoculum preparation, culture conditions, incubation, and interpretation criteria.
- The plate configuration and antibiotic concentrations may vary by product version; the laboratory should follow the current manufacturer instructions and applicable susceptibility-testing standards.
- Results should be interpreted with organism-specific breakpoints and quality-control procedures; an MIC result should not be used alone without clinical context.
- MRI safety, implant longevity, and patient contraindications do not apply because the plates are used outside the body.
Related Literature
The linked study examined the epidemiology of acute bacterial meningitis in adults in France, identifying Streptococcus pneumoniae and Haemophilus influenzae as leading pathogens. The study highlighted a decrease in antibiotic susceptibility among these bacteria, emphasizing the importance of accurate susceptibility testing. Limitations include its focus on a specific geographic region and potential changes in bacterial epidemiology since the study's publication.
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 Haemophilus Streptococcus Pneumoniae HP MIC Susceptibility Plates used for?
These plates are used to determine the minimum inhibitory concentration (MIC) of antibiotics against Haemophilus influenzae and Streptococcus pneumoniae.
What specialties typically use this device?
Microbiologists and infectious disease specialists typically use this device in laboratory settings.
What are the FDA-cleared indications?
The device is indicated 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.