510(k) · Cleared

Cleared

Elecsys CYFRA 21-1 CalCheck 5

K162173510(k) TraditionalCleared Jan 12, 2017162-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 Jan 12, 2017 as substantially equivalent to K150955 (Roche Diagnostics, 2015) after a 162-day review. Its family tree reaches back 4 generations to 2010.

Decided: Jan 12, 2017
Review: 162 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K093582 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK093582 Elecsys CK-MB Calcheck 5Roche Diagnostics · 2010
3 generations backK133284 Elecsys CK-MB Calcheck 5Roche Diagnostics · 2013
2 generations backK142127 Elecsys Estradiol Iii Calcheck 5Roche Diagnostics · 2014
1 generation backK150955 Elecsys Progesterone III Cal Check 5Roche Diagnostics · 2015
This deviceK162173 Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K093582	Elecsys CK-MB Calcheck 5	Roche Diagnostics	2010	—
−3	K133284	Elecsys CK-MB Calcheck 5	Roche Diagnostics	2013	—
−2	K142127	Elecsys Estradiol Iii Calcheck 5	Roche Diagnostics	2014	—
−1	K150955	Elecsys Progesterone III Cal Check 5	Roche Diagnostics	2015	—
0 (this device)	K162173	Elecsys CYFRA 21-1 CalCheck 5	Roche Diagnostics	2017	—

FIG. 1 — Lineage of K162173, 2010–2017Source: 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
*	K150955	Elecsys Progesterone III Cal Check 5 Summary page 6 …ndidate Device: Elecsys CYFRA Predicate Device: Elecsys Progesterone 21-1 CalCheck 5 III CalCheck 5 (K150955) Intended Use The Elecsys CYFRA 21-1 CalCheck 5 The Elecsys Progesterone III CalCheck 5…	Roche Diagnostics	2015	—

Also cleared against K150955: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 7 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K150955.

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. 2017, 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 CYFRA 21-1 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 CYFRA 21-1 reagent on the indicated Elecsys

and cobas e immunoassay analyzers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162173 · printed Nov 4, 2026

Cite this page

510(k) Report. “K162173: Elecsys CYFRA 21-1 CalCheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162173

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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