Elecsys Phospho-Tau (181P) Plasma
FDA 510(k) K252163 · Roche Diagnostics
510(k) numberK252163
Submission
- Device name
- Elecsys Phospho-Tau (181P) Plasma
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- July 10, 2025
- Decision date
- October 8, 2025
- 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 |
| K253240 | PrecivityAD2 TestSET · Traditional | C2N Diagnostics, LLC | 08/19/2026SE |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET · Traditional | Fujirebio Diagnostics,Inc. | 05/16/2025SE |
More from Fujirebio Diagnostics,Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Elecsys Phospho-Tau (181P) Plasma cleared by the FDA?
Elecsys Phospho-Tau (181P) Plasma (K252163) received a 510(k) decision of Substantially Equivalent on October 8, 2025, 90 days after the submission was received.
What is the product code of K252163?
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.