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New Allergen Disc - VAST Ventrex Allergy

by Ventrex Laboratories, Inc.

510(k) K831091

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831091 Date27 Apr 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
New Allergen Disc -Vast Ventex Allergy
510(k) Number
FDA Product Code
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The New Allergen Disc - VAST is a diagnostic disc used in Radioallergosorbent Test (RAST) systems for immunological analysis. It is designed to detect specific IgE antibodies in patient serum samples, aiding in the identification of allergic sensitivities to various allergens. This device falls under the category of immunological test systems, facilitating allergen-specific testing in clinical immunology settings.

The disc is supplied as a single-use diagnostic component within a RAST system and is intended for use in laboratory settings. It is classified as a Class II device under FDA regulations and has received 510(k) clearance (K831091) for substantial equivalence. The product code DHB identifies its regulatory classification, and it is not intended for MRI use or reusable applications. Storage and handling must comply with manufacturer guidelines to maintain sterility and accuracy of results.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VAST Allergen Disc used for in clinical settings?

    The VAST Allergen Disc is designed for use in Radioallergosorbent Test (RAST) systems to detect specific IgE antibodies in patient serum samples. This helps clinicians identify allergic sensitivities to various allergens, supporting accurate diagnosis and management of allergic conditions in laboratory settings.

  • Is the VAST Allergen Disc intended for single-use or reusable applications?

    The VAST Allergen Disc is explicitly intended for single-use only. It is supplied as a diagnostic component within a RAST system and must not be reused to ensure accurate and reliable test results.

  • What regulatory classification does the VAST Allergen Disc hold, and what clearance does it have?

    The VAST Allergen Disc is classified as a Class II medical device under FDA regulations. It has received 510(k) clearance (K831091) for substantial equivalence, confirming its compliance with FDA standards for immunological test systems.

  • How should the VAST Allergen Disc be stored and handled to maintain sterility?

    The VAST Allergen Disc must be stored and handled according to the manufacturer’s guidelines to preserve sterility and ensure the accuracy of test results. Proper storage conditions are critical to prevent contamination and maintain the integrity of the diagnostic component.

  • Can the VAST Allergen Disc be used with MRI equipment?

    No, the VAST Allergen Disc is explicitly not intended for MRI use. This limitation is noted in the product specifications to ensure safe and appropriate application within clinical settings.