510(k) · Cleared

Cleared

Elecsys Digoxin

K973112510(k) TraditionalCleared Oct 10, 199751-day reviewClass II21 CFR 862.3320

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

Boehringer Mannheim Corp. · KXT Enzyme Immunoassay, Digoxin

Cleared on Oct 10, 1997 as substantially equivalent to K882233 (Abbott Laboratories, 1988) after a 51-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided: Oct 10, 1997
Review: 51 days
Class: Class II
Product code: KXT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K882233 (1988). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK882233 TDX (R) Digoxin NXTAbbott Laboratories · 1988
This deviceK973112 Elecsys DigoxinBoehringer Mannheim Corp. · 1997
Descendant · cites it directly · 0 of its ownK153301 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics · 2016

Most influential descendants

Showing 1 of 1 · See all

K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882233	TDX (R) Digoxin NXT	Abbott Laboratories	1988	—
0 (this device)	K973112	Elecsys Digoxin	Boehringer Mannheim Corp.	1997	—
+1	K153301	Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II	Roche Diagnostics	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K973112, 1988–2016Source: 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 KXT? 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 KXT device

#1 K193397 ADVIA Centaur® Digoxin assayscore 1.7 · 1 generation · 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K882233	TDX (R) Digoxin NXT Summary page 1 …o other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® Digoxin II Assay (K882233). " Continued on next page page 26 BOEHRINGEH 0(K) Summary, Continued MANNHEIM CORPORATION 4. Device Descript…	Abbott Laboratories	1988	—

Also cleared against K882233: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K153301	Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II	Roche Diagnostics	2016	0

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, K153301 (Roche Diagnostics, 2016) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K882233.

How does its category compare?

All KXT devices

KXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXT

1in 2021

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXT

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

Recalls per year · KXT

1in 2008

2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KXT

7in 2024

2007high 310 (2007) · low 0 (2019)2025

MAUDE reports naming product code KXT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	3	310
2008	1	—	1	6
2009	0	—	0	9
2010	1	—	0	11
2011	1	—	0	19
2012	0	—	0	15
2013	0	—	0	39
2014	0	—	0	7
2015	0	—	0	1
2016	1	—	0	4
2017	0	—	0	19
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	5
2021	1	—	0	1
2022	0	—	0	3
2023	0	—	0	4
2024	0	—	0	7
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overdose and in

monitoring levels of digoxin to ensure proper therapy.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973112: Elecsys Digoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973112

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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