510(k) · Cleared
Recalled · Class II · 2017Elecsys Precicontrol Varia 3
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 8, 2011 as substantially equivalent to K082340 (Roche Diagnostics Corp., 2009) and 1 other predicate after a 37-day review. Its family tree reaches back 8 generations to 1993. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 8, 2011
- Review
- 37 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931172 (1993). 25 ancestors in all, the oldest K924862 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 7 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 6 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 5 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 4 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 3 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 2 generations backK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- 1 generation backK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- This deviceK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011
- Descendant · cites it directly · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 2 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK182012 ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018
Most influential descendants
Showing 3 of 3 · See all- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · cites it directly2descendants
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 2 generations on0descendants
- K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −7 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −6 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −4 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −3 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −2 | K051517 | Elecsys Precicontrol Anemia | Roche Diagnostics Corp. | 2005 | — |
| −1 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| 0 (this device) | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | — |
| +1 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +2 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +2 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Summary page 1…ducts in devices commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys®DPreciControl Anemia (K082340) and Elecsys® PreciControl Bone (KOS51543). Eleesys® PreciControl Varia 3 is a multi-analyte c… | 2009 |
| * | K051543 | Elecsys Precicontrol BoneSummary page 2…ecsys® PreciControl Varia 3 and the predicate devices, Elecsys®0 PreciControl Anemia (K082340, Table 1) and Eleesys® PreciControl Bone (K05 1543, Table 2). Tablet1. Comparison of Candidate (Elcsys®@ PreciControl Varia 3) and Predicate (Elecsys® PreciControl Anemi… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2017 | Class II | Z-2173-2017 | Process control | e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K132828 (Roche Diagnostics, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K082340.
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. 2011, 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 Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. See the package insert for the list of all analytes claimed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111506: Elecsys Precicontrol Varia 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111506
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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