Cleared Traditional

K253240 - PrecivityAD2 Test

K253240 is an FDA 510(k) clearance for PrecivityAD2 Test, manufactured by C2N Diagnostics, LLC. The device is a Class 2 Immunology device with product code SET cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K253240 · C2N Diagnostics, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
324d
Days
Class 2
Risk

K253240 is an FDA 510(k) clearance for the PrecivityAD2 Test. Classified as Immunoassay Blood Test For Amyloid Pathology Assessment (product code SET), Class II - Special Controls.

Submitted by C2N Diagnostics, LLC (St. Louis, US). The FDA issued a Cleared decision on August 19, 2026 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5840 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all C2N Diagnostics, LLC devices

FDA 510(k) Submission Details - K253240

510(k) Number K253240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date August 19, 2026
Days to Decision 324 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 105d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SET Device Classification - Class 2, Special Controls

Product Code SET Immunoassay Blood Test For Amyloid Pathology Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5840
Definition An Immunoassay Blood Test For Amyloid Pathology Assessment Is An In Vitro Diagnostic Test Used To Identify Patients With Amyloid Pathology Associated With Alzheimer’s Disease Who Have Signs And Symptoms Of Cognitive Decline. The Results Of The Test Are To Be Interpreted In Conjunction With Other Patient Clinical Information.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.