510(k) · Cleared
ClearedCrosslaps Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devices and Diagnostics Consulting Group · JMM Column Chromatography & Color Development, Hydroxyproline
Cleared on Dec 22, 1998 as substantially equivalent to K960171 (Diagnostic Systems Laboratories, Inc., 1996) after a 512-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it.
- Decided
- Dec 22, 1998
- Review
- 512 days
- Class
- Class I
- Product code
- JMM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960171 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960171 Active Crosslaps ElisaDiagnostic Systems Laboratories, Inc. · 1996
- This deviceK972788 Crosslaps ElisaDevices and Diagnostics Consulting Group · 1998
- Descendant · cites it directly · 6 of its ownK990843 Serum Crosslaps One Step ElisaOsteometer Biotech A/S · 1999
- Descendant · 2 generations on · 5 of its ownK993706 Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp. · 2000 · Recalled
- Descendant · 3 generations on · 4 of its ownK051543 Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005
- Descendant · 4 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 5 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K990843Serum Crosslaps One Step ElisaOsteometer Biotech A/S · 1999 · cites it directly6descendants
- K993706Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp. · 2000 · 2 generations on5descendants
- K051543Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005 · 3 generations on4descendants
- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 4 generations on3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960171 | Active Crosslaps Elisa | Diagnostic Systems Laboratories, Inc. | 1996 | — |
| 0 (this device) | K972788 | Crosslaps Elisa | Devices and Diagnostics Consulting Group | 1998 | — |
| +1 | K990843 | Serum Crosslaps One Step Elisa | Osteometer Biotech A/S | 1999 | — |
| +2 | K993706 | Elecsys Serum B-Crosslaps/Serum Immunoassay | Roche Diagnostics Corp. | 2000 | 1 |
| +3 | K051543 | Elecsys Precicontrol Bone | Roche Diagnostics Corp. | 2005 | — |
| +4 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +5 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K960171 | Active Crosslaps ElisaSummary page 1…titative measurement of Type I Collagen C-telopeptides is substantially equivalent to the DSL Active™ CrossLaps™ ELISA that was cleared by FDA in a previous submission (#K960171). The manufacture and specification of the device remains unchanged form those of the predicate device (#K960171). Only one mino… | 1996 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990843 | Serum Crosslaps One Step Elisa | 1999 | 6 |
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?
- Its one ancestor has no recall.
- Of its descendants, K990843 (Osteometer Biotech A/S, 1999) has gone furthest, with 6 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?
The CrossLaps™ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in: A. Monitoring bone resorption changes of 1.) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies 2.) Anti-resorptive therapies in individuals diagnosed with osteopenia; a) Hormone Replacement Therapies (HRT) with…
Read the full statement (113 words)
The CrossLaps™ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in:
A. Monitoring bone resorption changes of
1.) Anti-resorptive therapies in postmenopausal women:
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies
2.) Anti-resorptive therapies in individuals diagnosed with osteopenia;
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies
3.) Anti-resorptive therapies in individuals diagnosed with Paget’s disease of bone
B. Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies
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/K972788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972788: Crosslaps Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972788
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