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The Tracker / August 2026 / K253240

510(k) cleared

PrecivityAD2 Test

C2N Diagnostics, LLC · Aug 19, 2026 · K253240

FDA cleared the PrecivityAD2 Test from C2N Diagnostics, LLC on Aug 19, 2026 under K253240, a traditional 510(k). The device falls under product code SET, Immunoassay Blood Test For Amyloid Pathology Assessment, regulated at 21 CFR 866.5840 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Sep 29, 2025. The decision came 324 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 C2N Diagnostics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253240?

K253240 is the FDA 510(k) for PrecivityAD2 Test, submitted by C2N Diagnostics, LLC. FDA's decision date was Aug 19, 2026, under product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment).

Who makes the PrecivityAD2 Test?

C2N Diagnostics, LLC, based in St. Louis, MO, is the applicant of record for K253240.

How long did the K253240 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Aug 19, 2026, 324 days later.

← All decisions in August 2026