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phadiatop paediatric ria and eia
Pharmacia
Summary: The Phadiatop Paediatric RIA and EIA is a diagnostic tool used to detect allergies in children. It is primarily utilized by allergists and pediatricians to identify specific allergen sensitivities.
FDA Clearance Information
Pathway
510K
Number
K891135 ↗
Decision Date
May 9, 1989
Product Code
DHB
Device Class
Class 2
Evidence
0 studies
The Phadiatop Paediatric RIA and EIA, manufactured by Pharmacia, received FDA clearance via the 510(k) pathway on May 9, 1989. It is classified as a Class 2 device under product code DHB.
What It Is
The Phadiatop Paediatric RIA (Radioimmunoassay) and EIA (Enzyme Immunoassay) are diagnostic tests designed to identify allergen-specific IgE antibodies in pediatric patients. These assays help in diagnosing allergic conditions by detecting immune responses to various allergens. The tests are performed using blood samples and provide a comprehensive profile of potential allergen sensitivities in children.
Clinical Applications
These assays are commonly used in allergy clinics and pediatric settings to evaluate children suspected of having allergic conditions such as asthma, rhinitis, or eczema. They are particularly useful for identifying specific allergens that may trigger allergic reactions, aiding in the development of personalized management plans. Allergists and pediatricians use these tests to guide treatment decisions and monitor the effectiveness of interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in detecting allergen-specific IgE antibodies in children. It is used to evaluate children with suspected allergic conditions to identify specific allergen sensitivities.
Practical Considerations
The Phadiatop Paediatric RIA and EIA require a blood sample, typically collected via venipuncture. It is important to ensure proper sample handling and storage to maintain test accuracy. Compatibility with standard laboratory equipment for RIA and EIA is generally expected, but specific protocols may vary by facility.
Frequently Asked Questions
What is Phadiatop Paediatric RIA and EIA used for?
It is used to detect allergen-specific IgE antibodies in children, helping diagnose allergic conditions.
What specialties typically use this device?
Allergists and pediatricians commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for detecting allergen-specific IgE antibodies in pediatric patients to evaluate suspected allergic conditions.
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.