Cleared Traditional

K261027 - NOVEOS Specific IgE (sIgE)

Also marketed or referenced as:
Capture Reagent F014, Soybean (Glycine max) Capture Reagent F017, Hazelnut (Corylus avellana) Capture Reagent F352, Ara h 8 PR-10, Peanut Capture Reagent F423, Ara h 2, Peanut Capture Reagent F447, Ara h 6, Peanut

K261027 is an FDA 510(k) clearance for NOVEOS Specific IgE (sIgE), manufactured by Hycor Biomedical. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K261027 · Hycor Biomedical · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
116d
Days
Class 2
Risk

K261027 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 July 24, 2026 after a review of 116 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

FDA 510(k) Submission Details - K261027

510(k) Number K261027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2026
Decision Date July 24, 2026
Days to Decision 116 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
11d slower than avg
Panel avg: 105d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K261027.
NOVEOS Specific IgE (sIgE)
K260591 · Hycor Biomedical · Jul 2026
NOVEOS Specific IgE (sIgE)
K260280 · Hycor Biomedical · Jun 2026
NOVEOS Specific IgE (sIgE)
K260059 · Hycor Biomedical · May 2026
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