PrecivityAD2 Test
FDA 510(k) K253240 · C2N Diagnostics, LLC
510(k) numberK253240
Submission
- Device name
- PrecivityAD2 Test
- Applicant
- C2N Diagnostics, LLC
St. Louis, MO, US - Received
- September 29, 2025
- Decision date
- August 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SET – Immunoassay Blood Test For Amyloid Pathology Assessment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5840
- Specialty
- Immunology
An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimers 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.
Other 510(k)s with product code SET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | Roche Diagnostics | 08/19/2026SE |
| K252163 | Elecsys Phospho-Tau (181P) PlasmaSET · Traditional | Roche Diagnostics | 10/08/2025SE |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET · Traditional | Fujirebio Diagnostics,Inc. | 05/16/2025SE |
Questions and answers
When was PrecivityAD2 Test cleared by the FDA?
PrecivityAD2 Test (K253240) received a 510(k) decision of Substantially Equivalent on August 19, 2026, 324 days after the submission was received.
What is the product code of K253240?
The FDA product code is SET – Immunoassay Blood Test For Amyloid Pathology Assessment, a Class II (moderate risk) device regulated under 21 CFR 866.5840.