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haemophilus neisseria identif-panel
American Micro Scan
Summary: The haemophilus neisseria identif-panel by American Micro Scan is a diagnostic tool cleared by the FDA for identifying specific bacterial pathogens. Key evidence highlights its role in rapid diagnosis of bacterial infections.
FDA Clearance Information
Pathway
510K
Number
K833027 ↗
Decision Date
October 28, 1983
Product Code
—
Device Class
—
Evidence
419 studies
The haemophilus neisseria identif-panel was cleared by the FDA via the 510k pathway on October 28, 1983. Manufactured by American Micro Scan, it does not have a specific regulatory classification.
What It Is
The haemophilus neisseria identif-panel is a diagnostic device designed to identify bacterial pathogens, specifically Haemophilus influenzae and Neisseria meningitidis. It is intended for use in clinical settings to aid in the diagnosis of bacterial infections.
Clinical Applications
This device is commonly used in clinical scenarios where rapid identification of bacterial pathogens is critical, such as in cases of suspected bacterial meningitis or other systemic infections.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2005 and 2021. These studies provide insights into the diagnostic efficacy and clinical utility of the device.
Reported Outcomes
Published studies report that the haemophilus neisseria identif-panel is effective in rapidly identifying bacterial pathogens, which is crucial for timely treatment. The device has shown high sensitivity and specificity in detecting Haemophilus influenzae and Neisseria meningitidis.
Safety Profile
Reported complications include potential false positives or negatives, which could impact clinical decision-making. However, no significant adverse events directly related to the device's use have been documented.
Evidence Limitations
The evidence is limited by the small number of studies focusing specifically on this device. Further research is needed to explore its efficacy across diverse patient populations and in comparison to other diagnostic methods.
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 neisseria identif-panel?
The device is indicated for the identification of bacterial pathogens such as Haemophilus influenzae and Neisseria meningitidis in clinical settings.
What outcomes have been reported in clinical studies?
Studies report high sensitivity and specificity in pathogen detection, aiding in rapid diagnosis and treatment initiation.
What complications have been reported?
Reported complications include potential diagnostic inaccuracies, such as false positives or negatives.
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.