📋 FDA Reference
Haemophilus Streptococcus Pneumoniae HP Mic Plate
Trek Diagnostic Systems
Summary: The Haemophilus Streptococcus Pneumoniae HP MIC Plate is a diagnostic tool used to determine the minimum inhibitory concentration of antibiotics for specific pathogens. It is primarily used by microbiologists and infectious disease specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013368 ↗
Decision Date ?
November 20, 2001
Product Code ?
LTT
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on November 20, 2001. It is manufactured by Trek Diagnostic Systems and classified as a Class 2 device.
What It Is
The Haemophilus Streptococcus Pneumoniae HP MIC Plate is a diagnostic device used to assess the antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae. It works by exposing these bacteria to varying concentrations of antibiotics to determine the minimum inhibitory concentration (MIC) that effectively inhibits bacterial growth. This information is crucial for guiding appropriate antibiotic therapy.
FDA-Cleared Indications
- For in vitro determination of the antimicrobial susceptibility of Haemophilus influenzae.
- For in vitro determination of the antimicrobial susceptibility of Streptococcus pneumoniae.
- For determining minimum inhibitory concentrations of antimicrobial agents for these organisms.
Clinical Applications
- Testing clinical isolates of Haemophilus influenzae for susceptibility to antimicrobial agents.
- Testing clinical isolates of Streptococcus pneumoniae for susceptibility to antimicrobial agents.
- Providing MIC results to support selection or adjustment of antibiotic therapy.
- Supporting antimicrobial resistance surveillance and laboratory reporting for these organisms.
Practical Considerations
- This is an in vitro laboratory test system, not a device implanted in or used directly on a patient.
- Testing requires appropriate bacterial culture, inoculum preparation, incubation, contamination control, and interpretation according to current laboratory standards and labeling.
- MIC results should be interpreted with organism identification, specimen source, clinical status, and current susceptibility breakpoints.
- The plate must be used with compatible laboratory equipment and the antimicrobial concentrations provided by the manufacturer.
- It has no MRI safety classification because it is not intended for use in or on a patient during MRI.
Related Literature
The linked study examined the epidemiology of acute bacterial meningitis in adults in France, highlighting the prevalence of pathogens like Streptococcus pneumoniae and Haemophilus influenzae. It found a significant mortality rate, particularly in pneumococcal meningitis, and noted a decrease in antibiotic susceptibility. The study emphasized the impact of vaccination on reducing Haemophilus influenzae cases. Limitations include its focus on a specific geographic region and time period.
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 Plate used for?
It is used to determine the minimum inhibitory concentration of antibiotics for Haemophilus influenzae and Streptococcus pneumoniae, aiding in the selection of effective antibiotic therapy.
What specialties typically use this device?
Microbiologists and infectious disease specialists, particularly those working in clinical microbiology laboratories and hospitals.
What are the FDA-cleared indications?
The device is indicated for determining antibiotic susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to guide treatment decisions.
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.