Cleared Traditional

K242531 - NOVEOS Specific IgE (sIgE) Assay (FDA 510(k) Clearance)

Also includes:
Capture Reagent G010, Johnson Grass (Sorghum halepense) Capture Reagent T007, Oak (Quercus alba) Capture Reagent G002, Bermuda Grass (Cynodon dactylon) Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia) Capture Reagent E005, Dog Dander (Canis familiaris) Capture Reagent T003, Common Silver Birch (Betula verrucosa) Capture Reagent F001, Egg White (Gallus gallus) Capture Reagent F002, Cow's Milk (Bos taurus) NOVEOS Immunoassay Analyz
K242531 · Hycor Biomedical · Immunology device
Apr 2025
Decision
240d
Days
Class 2
Risk

K242531 is an FDA 510(k) clearance for the NOVEOS Specific IgE (sIgE) Assay. This device is classified as a System, Test, Radioallergosorbent (rast) Immunological (Class II - Special Controls, product code DHB).

Submitted by Hycor Biomedical (Garden Grove, US). The FDA issued a Cleared decision on April 23, 2025, 240 days after receiving the submission on August 26, 2024.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K242531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date April 23, 2025
Days to Decision 240 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB - System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.5750