510(k) · Cleared

Cleared

Elecsys T3 Calcheck 5

K111552510(k) TraditionalCleared Jul 21, 201148-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 · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Jul 21, 2011 as substantially equivalent to K963167 (Boehringer Mannheim Corp., 1996) after a 48-day review. Its family tree reaches back 2 generations to 1992. 16 later devices descend from it.

Decided: Jul 21, 2011
Review: 48 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K924862 (1992). 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
1 generation backK963167 Elecys Calcheck T 3Boehringer Mannheim Corp. · 1996
This deviceK111552 Elecsys T3 Calcheck 5Roche Diagnostics · 2011
Descendant · cites it directly · 15 of its ownK112528 Elecsys T4 Calcheck 5Roche Diagnostics Corporation · 2011
Descendant · 2 generations on · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
Descendant · cites it directly · 5 of its ownK133124 Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc. · 2013
Descendant · 3 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011high 3 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 16 · See all

K112528Elecsys T4 Calcheck 5Roche Diagnostics Corporation · 2011 · cites it directly15descendants
K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · 2 generations on8descendants
K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc. · 2013 · cites it directly5descendants
K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 3 generations on4descendants
K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924862	Aia-Pack HCG Calibration Verification Test Set	Tosoh Medics, Inc.	1992	—
−1	K963167	Elecys Calcheck T 3	Boehringer Mannheim Corp.	1996	—
0 (this device)	K111552	Elecsys T3 Calcheck 5	Roche Diagnostics	2011	—
+1	K112528	Elecsys T4 Calcheck 5	Roche Diagnostics Corporation	2011	—
+2	K113546	Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3…	Roche Diagnostics	2012	—
+1	K133124	Immulite 2000; Total T3 Calibration Verification Material, Total T4…	Siemens Healthcare Diagnostics, Inc.	2013	—
+3	K162840	Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D…	Roche Diagnostics	2017	2
+2	K140818	Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…	Siemens Healthcare Diagnostics, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	2	0
2014	3	0
2015	2	0
2017	3	0
2018	1	0
2021	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K111552, 1992–2026Source: 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

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
*	K963167	Elecys Calcheck T 3 Summary page 1 …lent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed T3 CalCheck (K963167). Device The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 in Description human serum matrix.…	Boehringer Mannheim Corp.	1996	—

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K112528	Elecsys T4 Calcheck 5	Roche Diagnostics Corporation	2011	15
K133124	Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…	Siemens Healthcare Diagnostics, Inc.	2013	5
K143687	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…	Siemens Healthcare Diagnostics, Inc.	2015	0

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 19 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K112528 (Roche Diagnostics Corporation, 2011) has gone furthest, with 15 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. 2011, this device’s year, is highlighted.

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 T3 CalCheck 5 is an assayed control for use in calibration verification and

for use in the verification of the assay range established by the Elecsys T3 reagent on the

indicated Elecsys and cobas e immunoassay analyzers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111552 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111552: Elecsys T3 Calcheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111552

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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