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detectadot system 2000 heterophile test
Gull Laboratories
Summary: The detectadot system 2000 heterophile test by Gull Laboratories is a diagnostic device used to detect heterophile antibodies. It is primarily used in the context of infectious mononucleosis. Key evidence highlights its role in identifying false positives in certain conditions.
FDA Clearance Information
Pathway
510K
Number
K895891 ↗
Decision Date
October 31, 1989
Product Code
KTN
Device Class
Class 2
Evidence
419 studies
The detectadot system 2000 heterophile test was cleared by the FDA via the 510(k) pathway on October 31, 1989. It is manufactured by Gull Laboratories and classified as a Class 2 device under product code KTN.
What It Is
The detectadot system 2000 heterophile test is a diagnostic tool designed to detect heterophile antibodies, often associated with infectious mononucleosis. It operates by identifying specific antibodies in the blood that react with antigens on red blood cells.
Clinical Applications
This device is commonly used in clinical settings to diagnose infectious mononucleosis, particularly in patients presenting with symptoms like fever, sore throat, and lymphadenopathy. It aids in differentiating mononucleosis from other conditions with similar presentations.
Evidence Summary
The available literature includes four studies, ranging from 2000 to 2016, encompassing various study types such as case series and other observational designs. These studies explore the test's diagnostic accuracy and potential for false positives.
Reported Outcomes
Published studies report that the detectadot system 2000 heterophile test is effective in detecting heterophile antibodies, with some cases of false positives noted, particularly in patients with rheumatoid arthritis or other autoimmune conditions. The test's utility in differentiating infectious mononucleosis from other conditions is highlighted.
Safety Profile
Reported complications include instances of false positive results, especially in patients with autoimmune disorders such as rheumatoid arthritis. No significant adverse events directly related to the device's use have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the observational nature of the research. Further research is needed to explore the test's specificity and sensitivity across diverse patient populations and to better understand the mechanisms leading to false positives.
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 detectadot system 2000 heterophile test?
The test is indicated for diagnosing infectious mononucleosis by detecting heterophile antibodies in patients with symptoms like fever and lymphadenopathy.
What outcomes have been reported in clinical studies?
Studies have shown the test effectively detects heterophile antibodies, with some false positives, particularly in autoimmune conditions.
What complications have been reported?
Safety data indicate false positives as a complication, especially in patients with autoimmune disorders, but no significant adverse events 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.