510(k) · Cleared

Cleared

Active Crosslaps Elisa

K960171510(k) TraditionalCleared Mar 28, 199672-day reviewClass I21 CFR 862.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostic Systems Laboratories, Inc. · JMM Column Chromatography & Color Development, Hydroxyproline

Cleared on Mar 28, 1996 after a 72-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided: Mar 28, 1996
Review: 72 days
Class: Class I
Product code: JMM
Recalls: None
Predicates: 0

8 later devices descend from it, 1 citing it directly.

This deviceK960171 Active Crosslaps ElisaDiagnostic Systems Laboratories, Inc. · 1996
Descendant · cites it directly · 7 of its ownK972788 Crosslaps ElisaDevices and Diagnostics Consulting Group · 1998
Descendant · 2 generations on · 6 of its ownK990843 Serum Crosslaps One Step ElisaOsteometer Biotech A/S · 1999
Descendant · 3 generations on · 5 of its ownK993706 Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp. · 2000 · Recalled
Descendant · 4 generations on · 4 of its ownK051543 Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005
Descendant · 5 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998high 1 (1998) · low 0 (2001)2026

Most influential descendants

Showing 5 of 8 · See all

K972788Crosslaps ElisaDevices and Diagnostics Consulting Group · 1998 · cites it directly7descendants
K990843Serum Crosslaps One Step ElisaOsteometer Biotech A/S · 1999 · 2 generations on6descendants
K993706Elecsys Serum B-Crosslaps/Serum ImmunoassayRoche Diagnostics Corp. · 2000 · 3 generations on5descendants
K051543Elecsys Precicontrol BoneRoche Diagnostics Corp. · 2005 · 4 generations on4descendants
K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960171	Active Crosslaps Elisa	Diagnostic Systems Laboratories, Inc.	1996	—
+1	K972788	Crosslaps Elisa	Devices and Diagnostics Consulting Group	1998	—
+2	K990843	Serum Crosslaps One Step Elisa	Osteometer Biotech A/S	1999	—
+3	K993706	Elecsys Serum B-Crosslaps/Serum Immunoassay	Roche Diagnostics Corp.	2000	1
+4	K051543	Elecsys Precicontrol Bone	Roche Diagnostics Corp.	2005	—
+5	K111506	Elecsys Precicontrol Varia 3	Roche Diagnostics	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2005	1	0
2011	1	0
2013	1	0
2018	1	0
2026	1	0

FIG. 1 — Lineage of K960171, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	—	OSTEX OSTEOMARK assay Named without a submission number			—

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K972788	Crosslaps Elisa	Devices and Diagnostics Consulting Group	1998	7

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?

Of its descendants, K972788 (Devices and Diagnostics Consulting Group, 1998) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JMM devices

JMM 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

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JMM

1in 2025

2007high 1 (2019) · low 0 (2007)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	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	1	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	1
2020	—	0	0
2021	—	0	1
2022	—	0	0
2023	—	0	1
2024	—	0	1
2025	—	0	1
2026	—	0	—

What is it indicated for?

The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.

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/K960171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960171: Active 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/K960171

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