đź“Š Evidence-Based Reference
Haemophilus Pneumococcus Mic Plate
Radiometer America
Summary: The haemophilus pneumococcus mic plate by Radiometer America is a diagnostic tool cleared by the FDA for identifying bacterial resistance. Key evidence includes studies on antibiotic resistance patterns.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K951241 ↗
Decision Date ?
October 7, 1995
Product Code ?
JWY
Device Class ?
Class 2
Evidence ?
419 studies
The haemophilus pneumococcus mic plate was cleared through the FDA 510(k) pathway on October 7, 1995. It is manufactured by Radiometer America and classified as a Class 2 device.
What It Is
The haemophilus pneumococcus mic plate is a diagnostic device used to assess bacterial resistance, particularly for Haemophilus influenzae and Streptococcus pneumoniae. It aids clinicians in selecting appropriate antimicrobial therapy.
FDA-Cleared Indications
- For in vitro antimicrobial susceptibility testing of Haemophilus influenzae.
- For in vitro antimicrobial susceptibility testing of Streptococcus pneumoniae.
- For use by qualified clinical microbiology laboratories to help determine bacterial susceptibility to antimicrobial agents.
Clinical Applications
- Testing Haemophilus influenzae isolates for susceptibility to applicable antibiotics.
- Testing Streptococcus pneumoniae isolates for susceptibility to applicable antibiotics.
- Supporting antimicrobial selection for infections caused by susceptible respiratory bacterial isolates.
- Generating laboratory susceptibility results for use with clinical findings and other microbiology data.
Evidence Summary
The literature includes 10 studies, primarily focusing on antibiotic resistance in respiratory pathogens. These studies range from 1996 to 2004 and include various study designs such as RCTs and prospective analyses.
Reported Outcomes
Published studies report that the haemophilus pneumococcus mic plate effectively identifies resistance patterns in Haemophilus influenzae and Streptococcus pneumoniae. The device aids in comparing the efficacy of different antibiotics, including macrolides and fluoroquinolones.
Safety Profile
Reported complications include potential inaccuracies in resistance detection due to variations in bacterial strains. No direct adverse events related to the device use were noted in the studies.
Evidence Limitations
The evidence is limited by the age of the studies, with the most recent being from 2004. Further research is needed to validate the device's efficacy with current bacterial strains and resistance patterns.
Practical Considerations
- This is an in vitro laboratory device, not an implant or device placed in a patient.
- Use is limited to the organisms, antimicrobial agents, specimen processing methods, and interpretation criteria described in the current labeling.
- Results require appropriate bacterial isolation, inoculum preparation, quality control, and interpretation by trained microbiology personnel.
- The plate has no MRI, vessel, anatomy, or patient-implant considerations because it is used outside the body.
- Susceptibility results should be interpreted with the organism identification, infection site, patient factors, and current laboratory standards.
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 haemophilus pneumococcus mic plate?
The device is indicated for identifying antibiotic resistance in Haemophilus influenzae and Streptococcus pneumoniae, aiding in treatment decisions for respiratory infections.
What outcomes have been reported in clinical studies?
Studies report effective identification of resistance patterns, facilitating the comparison of antibiotic efficacy, particularly for macrolides and fluoroquinolones.
What complications have been reported?
Reported complications include potential inaccuracies in resistance detection due to bacterial strain variations, though no direct adverse events were noted.
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.