Cleared Traditional

Aptiva APS IgA Reagent

K243979 · Inova Diagnostics, Inc. · Immunology
Feb 2026
Decision
410d
Days
Class 2
Risk

About This 510(k) Submission

K243979 is an FDA 510(k) clearance for the Aptiva APS IgA Reagent, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 6, 2026, 410 days after receiving the submission on December 23, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K243979 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2024
Decision Date February 06, 2026
Days to Decision 410 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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