510(k) · Cleared

Cleared

Elecsys C-Peptide Calcheck

K040157510(k) TraditionalCleared Feb 25, 200433-day reviewClass I21 CFR 862.1660

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

Roche Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Feb 25, 2004 as substantially equivalent to K031698 (Roche Diagnostics Corp., 2003) after a 33-day review. Its family tree reaches back 3 generations to 2000. 42 later devices descend from it.

Decided: Feb 25, 2004
Review: 33 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K001015 (2000). 42 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 3 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
2 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
1 generation backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
This deviceK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
Descendant · cites it directly · 32 of its ownK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
Descendant · cites it directly · 12 of its ownK051185 Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005
Descendant · 2 generations on · 11 of its ownK101365 Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010
Descendant · 3 generations on · 10 of its ownK122242 Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012
Descendant · 2 generations on · 10 of its ownK103221 Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics · 2010

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2005high 5 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 42 · See all

K100810Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010 · cites it directly32descendants
K051185Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005 · cites it directly12descendants
K101365Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010 · 2 generations on11descendants
K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012 · 3 generations on10descendants
K103221Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics · 2010 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K001015	Elecsys Thyroglobulin Calcheck	Roche Diagnostics Corp.	2000	—
−2	K020883	Elecsys Probnp Calcheck	Roche Diagnostics Corp.	2002	—
−1	K031698	Elecys SHBG Calcheck	Roche Diagnostics Corp.	2003	—
0 (this device)	K040157	Elecsys C-Peptide Calcheck	Roche Diagnostics Corp.	2004	—
+1	K100810	Elecsys C-Peptide Calcheck 5	Roche Diagnostics	2010	—
+1	K051185	Elecsys CA 19-9 Calcheck	Roche Diagnostics Corp.	2005	—
+2	K101365	Elecsys CA 19-9 Calcheck 5	Roche Diagnostics Corp.	2010	—
+3	K122242	Elecsys CA 15-3 II Calcheck 5	Roche Diagnostics	2012	—
+2	K103221	Elecys HGH Calset, Elecsys HGH Calcheck 5	Roche Diagnostics	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2009	5	0
2010	5	0
2011	3	0
2012	3	0
2013	2	0
2014	3	0
2015	1	0
2016	2	0
2017	4	0
2018	3	0
2019	3	0
2021	2	0
2022	1	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K040157, 2000–2026Source: 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 JJX? 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

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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
*	K031698	Elecys SHBG Calcheck Summary page 1 …unassayed) Predicate The Elecsys® C-Peptide CalCheck is substantially equivalent to the currently device marketed Elecsys® SHBG CalCheck (K031698). Device The Elecsys® C-Peptide CalCheck is a lyophilized product consisting of Description synthetic human…	Roche Diagnostics Corp.	2003	—

Also cleared against K031698: 1 other device →

What descends from it? (42)

See all 42

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100810	Elecsys C-Peptide Calcheck 5	Roche Diagnostics	2010	32
K051185	Elecsys CA 19-9 Calcheck	Roche Diagnostics Corp.	2005	12
K091601	Elecys Anti-CCP Calcheck	Roche Diagnostics Corp.	2009	1
K090311	Elecsys Rubella Igg Calcheck	Roche Diagnostics	2009	1
K083655	Elecsys Toxo Igg Calcheck	Roche Diagnostics	2009	1
K080643	Elecsys Anti-TSHR Calcheck	Roche Diagnostics	2008	1

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 4 years and passes through 1 company; a new generation was cleared every 9 months on median.
None of the 3 ancestors has a recall.
Of its descendants, K100810 (Roche Diagnostics, 2010) has gone furthest, with 32 descendants of its own.
1 other device also cites its predicate K031698.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040157 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040157: Elecsys C-Peptide Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040157

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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