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haemophilus influenzae type b
Scientific Device Laboratory
Summary: Haemophilus influenzae type b is a diagnostic device used for identifying the presence of the bacterium in clinical samples. It is primarily used in cases of suspected invasive disease. Key evidence highlights its role in reducing disease incidence through vaccination.
FDA Clearance Information
Pathway
510K
Number
K840506 ↗
Decision Date
April 4, 1984
Product Code
LSC
Device Class
Class 1
Evidence
419 studies
The device was cleared by the FDA through the 510k pathway on April 4, 1984. It is manufactured by Scientific Device Laboratory and is classified as a Class 1 device.
What It Is
The device is used to detect Haemophilus influenzae type b, a bacterium responsible for severe infections such as meningitis. It aids in the diagnosis of Hib-related diseases, particularly in vulnerable populations.
Clinical Applications
Commonly used in clinical settings to diagnose suspected cases of invasive Hib disease, especially in children and immunocompromised patients. It is crucial in guiding treatment decisions and public health interventions.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and meta-analyses, published between 2016 and 2025. These studies provide insights into the efficacy and safety of Hib vaccination and its impact on disease burden.
Reported Outcomes
Published studies report a significant reduction in invasive Hib disease incidence following vaccination. The Hib conjugate vaccine has shown prolonged efficacy in preventing severe infections. Studies also highlight the importance of vaccination in reducing nasopharyngeal carriage of the bacterium.
Safety Profile
Reported complications include rare cases of adverse reactions to the vaccine, though these are generally mild and self-limiting. No significant safety concerns have been consistently reported across the studies.
Evidence Limitations
The evidence is limited by a lack of recent large-scale studies specifically evaluating the diagnostic device. Further research is needed to assess long-term outcomes and the device's effectiveness in diverse populations.
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 influenzae type b?
The device is indicated for diagnosing infections caused by Haemophilus influenzae type b, particularly in cases of suspected invasive disease.
What outcomes have been reported in clinical studies?
Studies report a decrease in invasive disease incidence and highlight the vaccine's efficacy in preventing severe Hib infections.
What complications have been reported?
Reported complications include mild adverse reactions to the vaccine, with no significant safety issues 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.