510(k) · Cleared
ClearedElecsys Precicontrol Multianalyte
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 7, 2004 as substantially equivalent to K032089 (Roche Diagnostics Corp., 2003) after a 19-day review. Its family tree reaches back 5 generations to 1993. 19 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 19 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931172 (1993). 6 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 4 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 3 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 2 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 1 generation backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- This deviceK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- Descendant · cites it directly · 9 of its ownK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
- Descendant · 2 generations on · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- Descendant · cites it directly · 8 of its ownK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- Descendant · 2 generations on · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- Descendant · 3 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K102157Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010 · cites it directly9descendants
- K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · 2 generations on8descendants
- K051517Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005 · cites it directly8descendants
- K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp. · 2009 · 2 generations on7descendants
- K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −4 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| +1 | K102157 | Elecsys Precicontrol Multimarker | Roche Diagnostics | 2010 | — |
| +2 | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| +1 | K051517 | Elecsys Precicontrol Anemia | Roche Diagnostics Corp. | 2005 | — |
| +2 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| +3 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | 2 |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K032089 | Roche Diagnostics Elecsys Precicontrol CardiacSummary page 1…nassayed) Predicate The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the device currently marketed Elecsys® PreciControl Cardiac (K032089). Device The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting Description of synthetic hum… | 2003 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102157 (Roche Diagnostics, 2010) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K032089.
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?
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033937 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033937: Elecsys Precicontrol Multianalyte.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033937
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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