Radioallergosorbent Immunological Test System

A Radioallergosorbent Immunological Test System is a diagnostic medical device designed to identify specific IgE antibodies present in a patient’s blood. These antibodies are linked to allergic responses to certain allergens.

The process involves binding the allergen to a solid phase and subsequently quantifying the IgE antibodies that are attached, utilizing a radiolabeled anti-IgE antibody. In essence, this blood test aids in the diagnosis of allergies by pinpointing the specific allergens to which an individual exhibits sensitivity.

Intended Use of Radioallergosorbent (RAST) Immunological Test System

A Radioallergosorbent Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

Intended Use:

It is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). Specific IgE Assay is to be used with the Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

Device Description:

 The device is a Radioallergosorbent Immunological Test System intended for in vitro diagnostic use in measuring allergen-specific antibodies that cause allergic reactions, to aid in the diagnosis of asthma, allergies, and other related pulmonary disorders. The system consists of reagents and immunochemical components that bind allergen antibodies in patient specimens; the bound complexes are then detected and quantified using a labeled signal (such as a radioisotope or other detectable marker) that is proportional to the amount of specific antibody present. The measured signal is processed to generate a numerical result indicating the level of allergen-specific antibodies in the sample, which is used in conjunction with clinical evaluation to inform diagnosis and patient management.

Antibodies, Gliadin

Intended Use:

Enzyme linked immunosorbent assays (ELISA) for the qualitative or semi-quantitative detection of IgA or IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings.

Device Description:

The device is a Radioallergosorbent Immunological Test System intended for in vitro diagnostic use to detect and measure allergen-specific IgE antibodies in human serum or plasma specimens to aid in the diagnosis of allergic responses, including asthma and other allergic disorders. The test operates on an immunoassay principle, in which allergens immobilized on a solid phase bind allergen-specific IgE antibodies present in the patient sample; after washing, a labeled detection reagent binds the captured antibodies, and the resulting signal is measured. The intensity of the signal correlates with the amount of specific IgE antibody in the specimen and is processed to generate a quantitative or qualitative test result used in clinical evaluation of allergic sensitivity.

• Stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances

Clinical Testing:

No Guidance available for 510k submission