Cleared Traditional

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)

K243776 · Zeus Scientific · Immunology
May 2025
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K243776 is an FDA 510(k) clearance for the Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed), a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on May 7, 2025, 149 days after receiving the submission on December 9, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K243776 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2024
Decision Date May 07, 2025
Days to Decision 149 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

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