510(k) · Cleared
ClearedElecsys Precicontrol Cardiac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jul 22, 1996 as substantially equivalent to K961501 (Boehringer Mannheim Corp., 1996) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1993. 52 later devices descend from it.
- Decided
- Jul 22, 1996
- Review
- 21 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931172 (1993). 3 ancestors in all. 52 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 1 generation backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- This deviceK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 51 of its ownK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- Descendant · 2 generations on · 41 of its ownK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- Descendant · 3 generations on · 20 of its ownK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- Descendant · 3 generations on · 19 of its ownK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- Descendant · 4 generations on · 9 of its ownK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K983492Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998 · cites it directly51descendants
- K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003 · 2 generations on41descendants
- K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008 · 3 generations on20descendants
- K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004 · 3 generations on19descendants
- K102157Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −1 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| +2 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| +3 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| +3 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| +4 | K102157 | Elecsys Precicontrol Multimarker | Roche Diagnostics | 2010 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 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 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K961501 | Elecsys CK-MBSummary page 1…(Assayed and Unassayed) The Boehringer Mannheim Elecsys® PreciControl Cardiac 1and 2 are substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). The intended use has been changed to a quality control matenal. Continued on next page page 24 By D… | 1996 |
| * | K961500 | Elecsys Troponin TSummary page 1…nd Unassayed) The Boehringer Mannheim Elecsys® PreciControl Cardiac 1and 2 are substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). The intended use has been changed to a quality control matenal. Continued on next page page 24 By Diagnostics… | 1996 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | 1998 | 51 |
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 3 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K983492 (Boehringer Mannheim Corp., 1998) has gone furthest, with 51 descendants of its own.
- 1 other device also cites its predicate K961501.
How does its category compare?
All JJY devicesJJY 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 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?
Control for Elecsys® CK-MB and Troponin-T assays.
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/K962575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962575: Elecsys Precicontrol Cardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962575
Report an extraction error
Are you the manufacturer?
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