Quanticlone Ige Radioimmunassay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K852268 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Kallestad Laboratories, Inc. →

• What is the Quanticlone IGE Radioimmunoassay used for in clinical practice?

  The Quanticlone IGE Radioimmunoassay is designed to quantify Immunoglobulin E (IgE) antibodies in serum samples using radioimmunoassay technology. This helps clinicians diagnose and monitor allergic conditions, such as asthma and atopic disorders, by measuring IgE levels—a key marker in allergic responses.

• How is the Quanticlone IGE Radioimmunoassay supplied, and is it intended for single-use?

  The device is supplied as a laboratory kit for in vitro use. It is explicitly intended for single-use in controlled laboratory settings, requiring proper handling and disposal as a radioactive material due to its radioimmunoassay methodology.

• Does this device require special handling or regulatory compliance beyond standard laboratory procedures?

  Yes, because it uses radioactive materials, the Quanticlone IGE Radioimmunoassay must be handled according to regulatory standards for radioactive substances and immunodiagnostic reagents. The kit is classified under product code DGC and adheres to FDA Special Controls for Class II devices, ensuring compliance with safety protocols for radioactive diagnostics.

• What regulatory pathway was followed for FDA clearance of this device?

  The Quanticlone IGE Radioimmunoassay received FDA 510(k) clearance through a Traditional review pathway, with a decision of Substantially Equivalent (SESE). The submission was reviewed by the Immunology (IM) Advisory Committee and filed under the product code DGC, reflecting its classification as a diagnostic in vitro device.

• Is this device limited to specific laboratory settings, or can it be used in point-of-care environments?

  The Quanticlone IGE Radioimmunoassay is exclusively intended for laboratory use due to its reliance on radioimmunoassay technology and radioactive materials. Point-of-care settings typically lack the infrastructure for safe handling, disposal, and regulatory compliance required for this type of diagnostic device.