Cleared Traditional

K260059 - NOVEOS Specific IgE (sIgE) (FDA 510(k) Clearance)

Also includes:
Capture Reagent F018, Brazil Nut (Bertholletia excelsa) Capture Reagent F036, Coconut (Cocos nucifera) Capture Reagent F040, Tuna (Thunnus sp.) Capture Reagent F041, Salmon (Salmo salar) Capture Reagent F075, Egg Yolk (Gallus gallus) Capture Reagent F201, Pecan Nut (Carya illinoensis) Capture Reagent F203, Pistachio Nut (Pistacia vera) Capture Reagent F290, Oyster (Ostrea edulis)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260059 · Hycor Biomedical · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
127d
Days
Class 2
Risk

K260059 is an FDA 510(k) clearance for the NOVEOS Specific IgE (sIgE). Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hycor Biomedical (Garden Grove, US). The FDA issued a Cleared decision on May 15, 2026 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hycor Biomedical devices

Submission Details

510(k) Number K260059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2026
Decision Date May 15, 2026
Days to Decision 127 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 104d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 264
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K260059.
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775 · Hycor Biomedical · Jan 2026
NOVEOS Specific IgE (sIgE)
K252493 · Hycor Biomedical · Dec 2025
NOVEOS Specific IgE (sIgE) Assay
K242531 · Hycor Biomedical · Apr 2025
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
K212181 · Phadia AB · Aug 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
K220162 · Hycor Biomedical · Feb 2022
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613 · Hitachi Chemical Diagnostics, Inc. · Oct 2021