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reagent lyophilized anti-streptolysin o
Gamma Biologicals
Summary: The reagent lyophilized anti-streptolysin O by Gamma Biologicals is a diagnostic tool used to detect streptolysin O antibodies, indicating a recent streptococcal infection. It is primarily used by laboratory technicians and clinicians in diagnostic settings.
FDA Clearance Information
Pathway
510K
Number
K760096 ↗
Decision Date
August 3, 1976
Product Code
GTQ
Device Class
Class 1
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on August 3, 1976. Manufactured by Gamma Biologicals, it is classified as a Class 1 device under product code GTQ.
What It Is
The reagent lyophilized anti-streptolysin O is a diagnostic reagent used to detect antibodies against streptolysin O, a toxin produced by group A Streptococcus bacteria. It is typically used in serological tests to confirm recent streptococcal infections, such as rheumatic fever or post-streptococcal glomerulonephritis. The reagent is lyophilized, meaning it is freeze-dried for stability and long shelf life.
Clinical Applications
This device is commonly used in clinical laboratories to perform ASO titer tests, which help diagnose conditions related to recent streptococcal infections. It is particularly relevant in pediatrics and internal medicine, where it aids in the diagnosis of rheumatic fever and other post-streptococcal complications. The test is typically conducted in hospital laboratories or specialized diagnostic centers.
Indications for Use
The FDA indications suggest that this reagent is used for detecting antibodies to streptolysin O, which is useful in diagnosing recent streptococcal infections. It is particularly important for patients suspected of having complications like rheumatic fever.
Practical Considerations
The reagent is typically available in lyophilized form, requiring reconstitution before use. It is compatible with standard laboratory equipment used for serological testing. Proper technique in sample handling and reagent preparation is crucial for accurate results.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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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
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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
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PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
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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
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PubMed • 2025
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PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
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pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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
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PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
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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 is reagent lyophilized anti-streptolysin O used for?
It is used to detect antibodies against streptolysin O, indicating a recent streptococcal infection.
What specialties typically use this device?
Laboratory technicians, pediatricians, and internists commonly use this device for diagnostic purposes.
What are the FDA-cleared indications?
The device is indicated for detecting antibodies to streptolysin O, useful in diagnosing recent streptococcal infections and related complications.
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.