# K231348: Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 5, 2023 after 27 days
- Product code: QSE (Alzheimer’S Disease Pathology Assessment Test)
- Device class: 2
- Regulation: 21 CFR 866.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200072 (2022). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221842: Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF, Roche Diagnostics (2022) Summary page 4.

## Indications for use
Elecsys β-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β-Amyloid (1-42) (Abeta42) and Total-Tau (tTau) concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a tTau/Abeta42 ratio value. A negative result, defined as tTau/Abeta42 ratio value below cut-off or an Abeta42 value above the measuring range, is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive result, defined as tTau/Abeta42 ratio value above cut-off, is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. The tTau/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations. Limitations of Use The performance of the tTau/Abeta42 ratio has not been established for: ■ Predicting development of dementia or other neurologic conditions • Monitoring responses to therapies

Source page: https://510kreport.com/device/K231348
Methodology: https://510kreport.com/methodology