Cleared Traditional

K250408 - Alegria Flash ENA Screen

K250408 is an FDA 510(k) clearance for Alegria Flash ENA Screen, manufactured by Zeus Scientific. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K250408 · Zeus Scientific · Immunology device
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Sep 2025
Decision
218d
Days
Class 2
Risk

K250408 is an FDA 510(k) clearance for the Alegria Flash ENA Screen. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on September 19, 2025 after a review of 218 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 - K250408

510(k) Number K250408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2025
Decision Date September 19, 2025
Days to Decision 218 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 104d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 131
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K250408.
EliA CTD 13 Screen
K253367 · Phadia AB · Jun 2026
Alegria Flash CTD Screen
K250666 · Zeus Scientific · Oct 2025
Aptiva CTD Essential Reagent
K213403 · Inova Diagnostics, Inc. · Sep 2023
EliA SymphonyS Immunoassay
K190710 · Phadia AB · Nov 2019
QUANTA Flash HMGCR Reagents
K180975 · Inova Diagnostics, Inc. · Jun 2018
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
K152635 · Inova Diagnostics, Inc. · Jun 2016