510(k) · Cleared
ClearedPrecivityAD2 Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C2N Diagnostics, LLC · SET Immunoassay Blood Test For Amyloid Pathology Assessment
Cleared on Aug 19, 2026 as substantially equivalent to DEN200072 (Fujirebio Diagnostics,Inc., 2022) after a 324-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Aug 19, 2026
- Review
- 324 days
- Class
- Class II
- Product code
- SET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200072 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
- This deviceK253240 PrecivityAD2 TestC2N Diagnostics, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | 2022 | — |
| 0 (this device) | K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SET device
- #1 K261686 Elecsys Phospho-Tau (217P) Plasmascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40)Summary page 10…bmission IV. SUBSTANTIAL EQUIVALENCE INFORMATION: 1. Predicate Device Name Lumipulse G β-Amyloid Ratio (1-42/1-40) 2. Predicate 510(k) Number DEN200072 3. Comparison with Predicate A comparison of the PrecivityAD2 test and the predicate device, Fujirebio Lumipulse G β- Amyloid R… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN200072.
How does its category compare?
All SET devicesSET Immunoassay Blood Test For Amyloid Pathology Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SET
Too few SET 510(k)s in any year since 2007 to give a median.
Recalls per year · SET
No recall names SET since 2007.
Adverse event reports per year · SET
No MAUDE report names SET since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The PrecivityAD2 test is an in vitro device that uses immunoprecipitation followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantify β-Amyloid 1-42 (Aβ42) and β-Amyloid 1-40 (Aβ40) peptide concentrations, and phosphorylated and non-phosphorylated tau protein at amino acid threonine, position 217 (p-tau217 and np-tau217) peptide concentrations in human K2-EDTA plasma. An algorithm combines the Aβ42/40 ratio and the…
Read the full statement (159 words)
The PrecivityAD2 test is an in vitro device that uses immunoprecipitation followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantify β-Amyloid 1-42 (Aβ42) and β-Amyloid 1-40 (Aβ40) peptide concentrations, and phosphorylated and non-phosphorylated tau protein at amino acid threonine, position 217 (p-tau217 and np-tau217) peptide concentrations in human K2-EDTA plasma.
An algorithm combines the Aβ42/40 ratio and the p-tau217/np-tau217 ratio x 100 (%p-tau217) to generate the Amyloid Probability Score 2 (APS2) result, a numeric value ranging from 0-100.
The PrecivityAD2 test is indicated for use in adults aged 40 years and older who present with signs or symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline.
The PrecivityAD2 test is intended to be used in conjunction with clinical assessment to aid health care professionals experienced in the evaluation of cognitive impairment to identify patients with amyloid pathology associated with Alzheimer’s disease.
The test is not intended as a screening or stand-alone diagnostic test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253240: PrecivityAD2 Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253240
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026