510(k) · Cleared

Cleared

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

K231348510(k) TraditionalCleared Jun 5, 202327-day reviewClass II21 CFR 866.5840

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics · QSE Alzheimer’S Disease Pathology Assessment Test

Cleared on Jun 5, 2023 as substantially equivalent to K221842 (Roche Diagnostics, 2022) after a 27-day review. Its family tree reaches back 2 generations to 2022.

Decided: Jun 5, 2023
Review: 27 days
Class: Class II
Product code: QSE
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN200072 (2022). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
1 generation backK221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics · 2022
This deviceK231348 Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN200072	Lumipulse G ß-Amyloid Ratio (1-42/1-40)	Fujirebio Diagnostics,Inc.	2022	—
−1	K221842	Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF	Roche Diagnostics	2022	—
0 (this device)	K231348	Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF	Roche Diagnostics	2023	—

FIG. 1 — Lineage of K231348, 2022–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 QSE? 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 QSE device

#1 K221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys…score 10.5 · 1 generation · no Class I recall

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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	Applicant	Decided	Recalls
*	K221842	Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF Summary page 4 …Elecsys β-Amyloid (1-42) CSF II ratio for amyloid PET concordance Submission where 510k cleared K221842 Product Code QSE 21 CFR 807.92(a)(4)…	Roche Diagnostics	2022	—

Also cleared against K221842: 1 other device →

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?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 7 months on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K221842.

How does its category compare?

All QSE devices

QSE Alzheimer’S Disease Pathology Assessment Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · QSE

1in 2023

2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QSE

Too few QSE 510(k)s in any year since 2007 to give a median.

Recalls per year · QSE

No recall names QSE since 2007.

Adverse event reports per year · QSE

No MAUDE report names QSE since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	2	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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…

Read the full statement (176 words)

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231348: Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231348

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026