Ventrex Coated Tube IGE Enzyme Immunoassay

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

510(k) Number

K905636 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ventrex Laboratories, Inc. →

• What clinical conditions is this device primarily used to diagnose or monitor, and how does it work?

  This device is designed for diagnosing and monitoring allergic conditions such as asthma, hay fever, and food allergies by quantifying Immunoglobulin E (IgE) antibodies in serum or plasma samples. It uses enzyme-linked immunosorbent assay (ELISA) technology within a coated tube assay format to detect and measure specific IgE levels, helping clinicians assess allergy severity or response to treatment.

• Is this device intended for single-use or repeated use in a clinical setting?

  The Ventrex Coated Tube IGE Enzyme Immunoassay is explicitly supplied as a single-use kit, meaning each assay tube is intended for one test cycle only. This design ensures accuracy and prevents cross-contamination in clinical laboratory settings.

• What storage conditions should be followed for this device, and are there any special handling requirements?

  While specific storage conditions aren’t detailed in the provided data, this assay kit follows standard laboratory reagent protocols. It should be stored according to manufacturer guidelines (likely refrigerated or at room temperature, as is typical for ELISA reagents) to maintain stability and performance. No special sterility or MRI safety requirements are noted beyond routine laboratory handling.

• What regulatory pathway was followed for this device’s clearance, and which advisory committee reviewed it?

  This device received FDA clearance through a 510(k) submission, classified as *Traditional*, and was determined *Substantially Equivalent* to a predicate device. The review was conducted by the Immunology (IM) Advisory Committee, and the product falls under 21 CFR 866.5750 for immunological assays. The clearance number is K905636.