Cleared Traditional

Alegria Flash CTD Screen

K250666 · Zeus Scientific · Immunology
Oct 2025
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K250666 is an FDA 510(k) clearance for the Alegria Flash CTD Screen, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on October 22, 2025, 231 days after receiving the submission on March 5, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K250666 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2025
Decision Date October 22, 2025
Days to Decision 231 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

Similar Devices — LLL Extractable Antinuclear Antibody, Antigen And Control

All 179
Alegria Flash ENA Screen
K250408 · Zeus Scientific · Sep 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
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
K151429 · Inova Diagnostics, Inc. · Feb 2016