510(k) · Cleared
ClearedElecsys Precicontrol Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jul 2, 2009 as substantially equivalent to K051687 (Roche Diagnostics Corp., 2005) after a 122-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Jul 2, 2009
- Review
- 122 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931172 (1993). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 6 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 5 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 4 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 3 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 2 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 1 generation backK051687 Elecsys Precicontrol UniversalRoche Diagnostics Corp. · 2005
- This deviceK090541 Elecsys Precicontrol UniversalRoche Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK130469 Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2…DiaSorin, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −6 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −2 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −1 | K051687 | Elecsys Precicontrol Universal | Roche Diagnostics Corp. | 2005 | — |
| 0 (this device) | K090541 | Elecsys Precicontrol Universal | Roche Diagnostics | 2009 | — |
| +1 | K130469 | Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison… | DiaSorin, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K051687 | Elecsys Precicontrol UniversalSummary page 2…ontinued Predicate The Elecsys PreciControl Universal is substantially equivalent to the Device currently marketed Elecsys PreciControl Universal (PCU) K051687. Device The table below indicates the similarities between the modified Elecsys Comparison PreciControl Univers… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130469 | Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control… | 2013 | 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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K130469 (DiaSorin, Inc., 2013) has gone furthest, with 0 descendants of its own.
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. 2009, this device’s year, is highlighted.
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?
Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on
Elecsys and cobas e immunoassay analyzers.
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/K090541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090541: Elecsys Precicontrol Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090541
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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