510(k) · Cleared

Cleared

Elecsys Precicontrol Troponin T

K031990510(k) TraditionalCleared Aug 20, 200354-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

Roche Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Aug 20, 2003 as substantially equivalent to K983492 (Boehringer Mannheim Corp., 1998) after a 54-day review. Its family tree reaches back 4 generations to 1993. 8 later devices descend from it.

Decided: Aug 20, 2003
Review: 54 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K931172 (1993). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
3 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
2 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
1 generation backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
This deviceK031990 Elecsys Precicontrol Troponin TRoche Diagnostics Corp. · 2003
Descendant · cites it directly · 4 of its ownK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
Descendant · cites it directly · 2 of its ownK092322 Elecsys Rubella Igm ImmunoassayRoche Diagnostics · 2010
Descendant · 2 generations on · 1 of its ownK142133 Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014
Descendant · 2 generations on · 1 of its ownK111335 ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221…Tosoh Bioscience, Inc. · 2011 · Recalled
Descendant · 2 generations on · 0 of its ownK223867 Ids Acth IIImmunodiagnostic Systems Limited · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006high 2 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all

K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006 · cites it directly4descendants
K092322Elecsys Rubella Igm ImmunoassayRoche Diagnostics · 2010 · cites it directly2descendants
K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014 · 2 generations on1descendant
K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc. · 2011 · 2 generations on1descendant
K223867Ids Acth IIImmunodiagnostic Systems Limited · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K931172	Imx (R) Stat CK-MB	Abbott Laboratories	1993	—
−3	K961501	Elecsys CK-MB	Boehringer Mannheim Corp.	1996	—
−2	K962575	Elecsys Precicontrol Cardiac	Boehringer Mannheim Corp.	1996	—
−1	K983492	Boehringer Mannheim Elecsys Presicontrol Cardiac	Boehringer Mannheim Corp.	1998	—
0 (this device)	K031990	Elecsys Precicontrol Troponin T	Roche Diagnostics Corp.	2003	—
+1	K060585	Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth	Roche Diagnostics Corp.	2006	—
+1	K092322	Elecsys Rubella Igm Immunoassay	Roche Diagnostics	2010	—
+2	K142133	Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm	Roche Diagnostics	2014	—
+2	K111335	ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321	Tosoh Bioscience, Inc.	2011	2
+2	K223867	Ids Acth II	Immunodiagnostic Systems Limited	2023	—

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
2006	1	0
2010	1	0
2011	1	0
2013	1	0
2014	2	0
2017	1	0
2023	1	0

FIG. 1 — Lineage of K031990, 1993–2023Source: 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 JJX? 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
*	K983492	Boehringer Mannheim Elecsys Presicontrol Cardiac	Boehringer Mannheim Corp.	1998	—

Also cleared against K983492: 1 other device →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K060585	Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth	Roche Diagnostics Corp.	2006	4
K092322	Elecsys Rubella Igm Immunoassay	Roche Diagnostics	2010	2

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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K060585 (Roche Diagnostics Corp., 2006) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K983492.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

PreciControl Troponin T is used for quality control of the Elecsys Troponin T (CARDIAC T) immunoassay of the Elecsys immunoassay systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031990 · printed Nov 3, 2026

Cite this page

510(k) Report. “K031990: Elecsys Precicontrol Troponin T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031990

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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