510(k) · Cleared

Cleared

Elecsys Thyroglobulin Calcheck

K001015510(k) TraditionalCleared Apr 27, 200029-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 Apr 27, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.

Decided: Apr 27, 2000
Review: 29 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 0

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

This deviceK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
Descendant · cites it directly · 47 of its ownK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
Descendant · 2 generations on · 44 of its ownK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
Descendant · 3 generations on · 42 of its ownK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
Descendant · 4 generations on · 32 of its ownK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
Descendant · 4 generations on · 12 of its ownK051185 Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2002high 6 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 48 · See all

K020883Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002 · cites it directly47descendants
K031698Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003 · 2 generations on44descendants
K040157Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004 · 3 generations on42descendants
K100810Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010 · 4 generations on32descendants
K051185Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005 · 4 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001015	Elecsys Thyroglobulin Calcheck	Roche Diagnostics Corp.	2000	—
+1	K020883	Elecsys Probnp Calcheck	Roche Diagnostics Corp.	2002	—
+2	K031698	Elecys SHBG Calcheck	Roche Diagnostics Corp.	2003	—
+3	K040157	Elecsys C-Peptide Calcheck	Roche Diagnostics Corp.	2004	—
+4	K100810	Elecsys C-Peptide Calcheck 5	Roche Diagnostics	2010	—
+4	K051185	Elecsys CA 19-9 Calcheck	Roche Diagnostics Corp.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2005	1	0
2008	2	0
2009	6	0
2010	5	0
2011	4	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 K001015, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (48)

See all 48

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

Number	Device	Applicant	Decided	Descendants
K020883	Elecsys Probnp Calcheck	Roche Diagnostics Corp.	2002	47

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, K020883 (Roche Diagnostics Corp., 2002) has gone furthest, with 47 descendants of its own.

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	—

https://510kreport.com/device/K001015 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001015: Elecsys Thyroglobulin Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001015

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026