510(k) · Cleared

Cleared

Boehringer Mannheim Elecsys Presicontrol Cardiac

K983492510(k) TraditionalCleared Oct 9, 19984-day reviewClass I21 CFR 862.1660

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

Boehringer Mannheim Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Oct 9, 1998 as substantially equivalent to K962575 (Boehringer Mannheim Corp., 1996) after a 4-day review. Its family tree reaches back 3 generations to 1993. 51 later devices descend from it.

Decided: Oct 9, 1998
Review: 4 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K931172 (1993). 4 ancestors in all. 51 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
2 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
1 generation backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
This deviceK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
Descendant · cites it directly · 41 of its ownK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
Descendant · 2 generations on · 20 of its ownK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
Descendant · 2 generations on · 19 of its ownK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
Descendant · 3 generations on · 9 of its ownK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
Descendant · 3 generations on · 9 of its ownK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · Recalled

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2003high 5 (2017) · low 0 (2007)2026

Most influential descendants

Showing 5 of 51 · See all

K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003 · cites it directly41descendants
K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008 · 2 generations on20descendants
K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004 · 2 generations on19descendants
K102157Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010 · 3 generations on9descendants
K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K931172	Imx (R) Stat CK-MB	Abbott Laboratories	1993	—
−2	K961501	Elecsys CK-MB	Boehringer Mannheim Corp.	1996	—
−1	K962575	Elecsys Precicontrol Cardiac	Boehringer Mannheim Corp.	1996	—
0 (this device)	K983492	Boehringer Mannheim Elecsys Presicontrol Cardiac	Boehringer Mannheim Corp.	1998	—
+1	K032089	Roche Diagnostics Elecsys Precicontrol Cardiac	Roche Diagnostics Corp.	2003	—
+2	K072437	Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset	Roche Diagnostics	2008	—
+2	K033937	Elecsys Precicontrol Multianalyte	Roche Diagnostics Corp.	2004	—
+3	K102157	Elecsys Precicontrol Multimarker	Roche Diagnostics	2010	—
+3	K082699	Elecsys Troponin I and Troponin I Stat Test Systems	Roche Diagnostics	2009	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	2	0
2006	1	0
2008	1	0
2009	3	0
2010	3	0
2011	3	0
2012	1	0
2013	3	0
2014	3	0
2016	1	0
2017	5	0
2018	3	0
2019	3	0
2021	3	0
2022	2	0
2023	5	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K983492, 1993–2026Source: 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 JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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
*	K962575	Elecsys Precicontrol Cardiac Summary page 1 …n name: Elecsys ® PreciControl Cardiac Classification name: Enzyme Controls (assayed and unassayed) We claim substantial equivalence to Elecsys ® PreciControl Cardiac (K962575). Boehringer Mannheim Elecsys ® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB…	Boehringer Mannheim Corp.	1996	—

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K032089	Roche Diagnostics Elecsys Precicontrol Cardiac	Roche Diagnostics Corp.	2003	41
K031990	Elecsys Precicontrol Troponin T	Roche Diagnostics Corp.	2003	8

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 5 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K032089 (Roche Diagnostics Corp., 2003) has gone furthest, with 41 descendants of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

Elecsys ® PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®) and Myoglobin immunoassays using the Elecsys immunoassay systems.

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/K983492 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983492: Boehringer Mannheim Elecsys Presicontrol Cardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983492

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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