510(k) · Cleared
Recalled · Class II · 2013Elecsys Serum B-Crosslaps/Serum Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JMM Column Chromatography & Color Development, Hydroxyproline
Cleared on Jul 24, 2000 as substantially equivalent to K990843 (Osteometer Biotech A/S, 1999) after a 265-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 2000
- Review
- 265 days
- Class
- Class I
- Product code
- JMM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960171 (1996). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960171 Active Crosslaps ElisaDiagnostic Systems Laboratories, Inc. · 1996
- 2 generations backK972788 Crosslaps ElisaDevices and Diagnostics Consulting Group · 1998
- 1 generation backK990843 Serum Crosslaps One Step ElisaOsteometer Biotech A/S · 1999
- This deviceK993706 Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp. · 2000
- Descendant · cites it directly · 4 of its ownK051543 Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005
- Descendant · 2 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 4 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · 4 generations on · 0 of its ownK182012 ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018
Most influential descendants
Showing 5 of 5 · See all- K051543Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005 · cites it directly4descendants
- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 2 generations on3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 3 generations on2descendants
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 4 generations on0descendants
- K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960171 | Active Crosslaps Elisa | Diagnostic Systems Laboratories, Inc. | 1996 | — |
| −2 | K972788 | Crosslaps Elisa | Devices and Diagnostics Consulting Group | 1998 | — |
| −1 | K990843 | Serum Crosslaps One Step Elisa | Osteometer Biotech A/S | 1999 | — |
| 0 (this device) | K993706 | Elecsys Serum B-Crosslaps/Serum Immunoassay | Roche Diagnostics Corp. | 2000 | — |
| +1 | K051543 | Elecsys Precicontrol Bone | Roche Diagnostics Corp. | 2005 | — |
| +2 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +3 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +4 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +4 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 JMM? 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 |
|---|---|---|---|
| * | K990843 | Serum Crosslaps One Step ElisaSummary page 1…/serum Immunoassay is substantially _equivalent to other devices marketed in the United States. We claim equivalence to the Osteometer Serum CrossLaps™ One Step ELISA (K990843). Device name Proprietary name ELECSYS® B-CrossLaps/serum Immunoassay Common name Electrochemiluminescence Immunoassay, B-Cros… | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051543 | Elecsys Precicontrol Bone | 2005 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2013 | Class II | Z-1727-2013 | Device Design | Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ¿-CrossLaps (¿-CL) assay package insert version 5, could not be reproduced. The ¿-CrossLaps… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K051543 (Roche Diagnostics Corp., 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JMM devicesJMM Column Chromatography & Color Development, Hydroxyproline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMM
FDA has decided no JMM device since 2007.
Median 510(k) review, days · JMM
Too few JMM 510(k)s in any year since 2007 to give a median.
Recalls per year · JMM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMM
1in 2025
MAUDE reports naming product code JMM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma, for assessing individual bone resorption. The test may be used as an aid in monitoring anti-resorptive therapies (e.g. bisphosphonates, hormone replacement therapy — HRT) in postmenopausal women and individuals diagnosed with osteopenia. The elecrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche ELECSYS 1010 and 2010 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/K993706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993706: Elecsys Serum B-Crosslaps/Serum Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993706
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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