Phadebas Rast Test Allergen Discs

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

510(k) Number

K852189 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Phadebas Rast Allergen Discs

  Class II

  FDA 510(k) K823841 Active Cleared 12 Jan 1983

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  Class I

  FDA 510(k) K830445 Active Cleared 27 Apr 1983

• Delfia Plate Fluorometer 1232

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  FDA 510(k) K895240 Active Cleared 4 Oct 1989

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  FDA 510(k) K970420 Active Cleared 30 Jun 1997

• Phadebas Igg Rast Test

  Class II

  FDA 510(k) K810694 Active Cleared 23 Jul 1981

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• What is the Phadebas RAST Test Allergen Discs used for?

  The Phadebas RAST Test Allergen Discs are an in vitro diagnostic tool designed for radioallergosorbent testing (RAST). They measure specific IgE antibodies in human serum to identify allergic sensitivities to various allergens. This helps clinicians diagnose allergies by quantifying allergen-specific IgE levels in a standardized way.

• Are the Phadebas RAST Allergen Discs sterile?

  No, the Phadebas RAST Allergen Discs are not sterile. They are intended for single-use in laboratory settings and must be handled according to standard in vitro diagnostic device protocols to ensure proper performance and safety.

• How are the Phadebas RAST Allergen Discs supplied and stored?

  The discs are supplied as a single-use diagnostic tool for laboratory use only. Storage and handling must comply with standard laboratory protocols for in vitro diagnostics. This includes maintaining appropriate environmental conditions to preserve their integrity and functionality.

• Can these discs be reused?

  No, the Phadebas RAST Allergen Discs are explicitly designed for single-use only. Reuse is not recommended or supported, as it could compromise accuracy and reliability of the test results.

• What regulatory pathway was followed for clearance of these allergen discs?

  The Phadebas RAST Test Allergen Discs received FDA 510(k) clearance through the Traditional review pathway. They are classified as a Class II device under FDA regulations, with the decision described as substantially equivalent to a predicate device. The clearance was granted by the Immunology (IM) Advisory Committee.