510(k) · Cleared
ClearedElecsys Precicontrol Bone
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 Oct 17, 2005 as substantially equivalent to K993706 (Roche Diagnostics Corp., 2000) after a 129-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 129 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960171 (1996). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK960171 Active Crosslaps ElisaDiagnostic Systems Laboratories, Inc. · 1996
- 3 generations backK972788 Crosslaps ElisaDevices and Diagnostics Consulting Group · 1998
- 2 generations backK990843 Serum Crosslaps One Step ElisaOsteometer Biotech A/S · 1999
- 1 generation backK993706 Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp. · 2000 · Recalled
- This deviceK051543 Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005
- Descendant · cites it directly · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 3 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · 3 generations on · 0 of its ownK182012 ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018
Most influential descendants
Showing 4 of 4 · See all- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · cites it directly3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 2 generations on2descendants
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 3 generations on0descendants
- K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960171 | Active Crosslaps Elisa | Diagnostic Systems Laboratories, Inc. | 1996 | — |
| −3 | K972788 | Crosslaps Elisa | Devices and Diagnostics Consulting Group | 1998 | — |
| −2 | K990843 | Serum Crosslaps One Step Elisa | Osteometer Biotech A/S | 1999 | — |
| −1 | K993706 | Elecsys Serum B-Crosslaps/Serum Immunoassay | Roche Diagnostics Corp. | 2000 | 1 |
| 0 (this device) | K051543 | Elecsys Precicontrol Bone | Roche Diagnostics Corp. | 2005 | — |
| +1 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +2 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +3 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +3 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K993706 | Elecsys Serum B-Crosslaps/Serum ImmunoassaySummary page 1…oassays on Elecsys immunoassay systems. Predicate We claim substantial equivalence to the currently marketed Elecsys®k Device PreciControl Bone (K993706). Roche Diagnostics 2 Confidential === Page 2… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111506 | Elecsys Precicontrol Varia 3 | 2011 | 3 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K111506 (Roche Diagnostics, 2011) has gone furthest, with 3 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.
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?
PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051543: Elecsys Precicontrol Bone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051543
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