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hp-haemophilus pneumococcus mic plate
Sensititre Microbiology A Div. Of Radiometer
Summary: The hp-haemophilus pneumococcus mic plate is a diagnostic tool used for susceptibility testing of bacterial strains. It is primarily used in clinical microbiology to guide antibiotic therapy. Key evidence highlights its role in determining resistance patterns in pathogens like Streptococcus pneumoniae.
FDA Clearance Information
Pathway
510K
Number
K912778 ↗
Decision Date
February 18, 1992
Product Code
JWY
Device Class
Class 2
Evidence
419 studies
The hp-haemophilus pneumococcus mic plate was cleared by the FDA via the 510(k) pathway on February 18, 1992. It is manufactured by Sensititre Microbiology A Div. Of Radiometer and classified as a Class 2 device.
What It Is
The hp-haemophilus pneumococcus mic plate is a diagnostic device designed for the susceptibility testing of bacterial pathogens. It is used in clinical laboratories to determine the minimum inhibitory concentration (MIC) of antibiotics against specific bacteria, aiding in the selection of appropriate antimicrobial therapy.
Clinical Applications
This device is commonly used in clinical settings for the diagnosis and management of infections caused by Haemophilus and Streptococcus pneumoniae. It helps clinicians identify effective antibiotics for treatment, particularly in cases of suspected or confirmed bacterial resistance.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and other study types. These studies span from recent years, with the latest published in 2024, focusing on the device's efficacy in susceptibility testing.
Reported Outcomes
Published studies report that the hp-haemophilus pneumococcus mic plate effectively determines antibiotic susceptibility, with high agreement rates in comparison to other methods like agar disk diffusion. For example, a study highlighted an 80.7% agreement rate for broth microdilution. The device is instrumental in identifying resistance patterns in pathogens such as Streptococcus pneumoniae.
Safety Profile
Reported complications include discrepancies in susceptibility testing results, which can impact clinical decision-making. However, no direct adverse events related to the device's use have been documented in the provided evidence.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, multicenter trials. Further research is needed to validate the device's efficacy across diverse clinical settings and to explore its performance in detecting emerging resistance patterns.
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 are the clinical indications for hp-haemophilus pneumococcus mic plate?
The device is indicated for susceptibility testing of bacterial pathogens, particularly Haemophilus and Streptococcus pneumoniae, to guide antibiotic therapy.
What outcomes have been reported in clinical studies?
Studies report high agreement rates in susceptibility testing, with significant findings in identifying resistance patterns in pathogens like Streptococcus pneumoniae.
What complications have been reported?
Safety data indicate potential discrepancies in test results, but no direct adverse events related to the device's use have been reported.
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.