PrecivityAD2 Test— 510(k) K253240

Name: FDA 510(k) clearance K253240
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Substantially Equivalent

C2N Diagnostics, LLC

FDA 510(k) clearance K253240 for PrecivityAD2 Test, Substantially Equivalent on 2026-08-19. Applicant: C2N Diagnostics, LLC. Device class: 2.

Summary

C2N Diagnostics' PrecivityAD2 Test is filed under product code SET, immunoassay blood tests for amyloid pathology assessment. The record doesn't describe the test beyond its name and that code.

Class II, 21 CFR 866.5840. Immunology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

C2N filed from St. Louis, Missouri. The substantially equivalent decision came 324 calendar days after receipt (September 29, 2025 to August 19, 2026).

Clearance details

Applicant: C2N Diagnostics, LLC
Product code: Product code SET
Device class: Class 2
Regulation: 21 CFR 866.5840
Advisory panel: Immunology
Date received: 2025-09-29
Decision date: 2026-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.