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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K243979

510(k) cleared

Aptiva APS IgA Reagent

Inova Diagnostics, Inc. · Feb 6, 2026 · K243979

FDA cleared the Aptiva APS IgA Reagent from Inova Diagnostics, Inc. on Feb 6, 2026 under K243979, a traditional 510(k). The device falls under product code MSV, System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), regulated at 21 CFR 866.5660 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Dec 23, 2024. The decision came 410 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Inova Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243979?

K243979 is the FDA 510(k) for Aptiva APS IgA Reagent, submitted by Inova Diagnostics, Inc.. FDA's decision date was Feb 6, 2026, under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)).

Who makes the Aptiva APS IgA Reagent?

Inova Diagnostics, Inc., based in San Diego, CA, is the applicant of record for K243979.

How long did the K243979 review take?

FDA received the submission on Dec 23, 2024 and issued its decision on Feb 6, 2026, 410 days later.

← All decisions in February 2026