510(k) Report

510(k) · Cleared

Cleared

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

K221842510(k) TraditionalCleared Dec 7, 2022166-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 Dec 7, 2022 as substantially equivalent to DEN200072 (Fujirebio Diagnostics,Inc., 2022) after a 166-day review. Its family tree reaches back 1 generation to 2022. 2 later devices descend from it.

Decided
Dec 7, 2022
Review
166 days
Class
Class II
Product code
QSE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN200072 (2022). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared2025: 1 descendant clearedDEN200072 · Lumipulse G ß-Amyloid Ratio (1-42/1-40) · Fujirebio Diagnostics,Inc. · 20222020202220242026
Descendants, by generation 1 generation forward: 2 descendants DEN200072 · Lumipulse G ß-Amyloid Ratio (1-42/1-40) · Fujirebio Diagnostics,Inc. · 20220
  1. Root · 1 generation backDEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
  2. This deviceK221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics · 2022
  3. Descendant · cites it directly · 0 of its ownK252163 Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics · 2025
  4. Descendant · cites it directly · 0 of its ownK231348 Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics · 2025 · cites it directly0descendants
  • K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc.2022—
0 (this device)K221842Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics2022—
+1K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics2025—
+1K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202510
FIG. 1 — Lineage of K221842, 2022–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231348 Elecsys ß-Amyloid (1-42) CSF II, Elecsys…score 5.8 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)
Summary page 4
…21 CFR 807.92(a)(3) Predicate Device Lumipulse G β-Amyloid Ratio (1-42/1-40) Submission where de novo was granted DEN200072 Product Code QSE 21 CFR 807.92(a)(4)…
Fujirebio Diagnostics,Inc.2022—

Also cleared against DEN200072: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics20250
K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics20230

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.
  • Of its descendants, K252163 (Roche Diagnostics, 2025) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate DEN200072.

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. 2022, this device’s year, is highlighted.

FDA decisions per year · QSE

1in 2023

2022: 22023: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20222—00
20231—00
20240—00
20250—00
20260—0—

What is it indicated for?

Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β-Amyloid (1-42) (Abeta42) and Phospho-Tau (181P) (pTau181) protein 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 pTau181/Abeta42 ratio value. A negative result, defined…

Read the full statement (179 words)

Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β-Amyloid (1-42) (Abeta42) and Phospho-Tau (181P) (pTau181) protein 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 pTau181/Abeta42 ratio value.

A negative result, defined as pTau181/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 pTau181/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 pTau181/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations.

Limitations of Use

The performance of the pTau181/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.

Also cleared against DEN200072

3 other devices cite the same predicate.

  • K253240PrecivityAD2 TestC2N Diagnostics, LLC · 2026
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20257 recalls
  • K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 20241 Class I recall

More from Roche Diagnostics

207 FDA decisions under this applicant name. See the company

  • DEN260027Elecsys HBsAg II quant II RxDxRoche Diagnostics · 2026
  • K260232Elecsys EBV VCA IgGRoche Diagnostics · 2026
  • K260233Elecsys EBV IgMRoche Diagnostics · 2026
  • K260221Elecsys EBV EBNA IgGRoche Diagnostics · 2026
  • K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics · 2026

Recent decisions in QSE

The QSE category page

  • K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics · 2023
  • DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022

https://510kreport.com/device/K221842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221842: Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221842

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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