Cleared Traditional

K261466 - Alegria Flash MPO

Also marketed or referenced as:
Alegria Flash PR3 Alegria Flash GBM

K261466 is an FDA 510(k) clearance for Alegria Flash MPO, manufactured by Zeus Scientific. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K261466 · Zeus Scientific · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
109d
Days
Class 2
Risk

K261466 is an FDA 510(k) clearance for the Alegria Flash MPO. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on August 21, 2026 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Zeus Scientific devices

FDA 510(k) Submission Details - K261466

510(k) Number K261466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2026
Decision Date August 21, 2026
Days to Decision 109 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
4d slower than avg
Panel avg: 105d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 62
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K261466.
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)
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K173792 · Phadia AB · Mar 2018
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K161258 · Inova Diagnostics, Inc. · Feb 2017
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225 · Phadia US, Inc. · Oct 2014