510(k) · Cleared

Cleared

Elecsys Folate Iii Calcheck 5

K094031510(k) TraditionalCleared Apr 27, 2010118-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 Apr 27, 2010 as substantially equivalent to K092168 (Roche Diagnostics, 2009) after a 118-day review. Its family tree reaches back 2 generations to 2001.

Decided: Apr 27, 2010
Review: 118 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010237 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010237 Elecsys HCG+B CalcheckRoche Diagnostics Corp. · 2001
1 generation backK092168 Elecsys HCG+B Calcheck 5Roche Diagnostics · 2009
This deviceK094031 Elecsys Folate Iii Calcheck 5Roche Diagnostics · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010237	Elecsys HCG+B Calcheck	Roche Diagnostics Corp.	2001	—
−1	K092168	Elecsys HCG+B Calcheck 5	Roche Diagnostics	2009	—
0 (this device)	K094031	Elecsys Folate Iii Calcheck 5	Roche Diagnostics	2010	—

FIG. 1 — Lineage of K094031, 2001–2010Source: 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
*	K092168	Elecsys HCG+B Calcheck 5 Summary page 1 …products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys HCG+0 CalCheck 5 (K092 168). Device The Elecsys Folate Ill CalCheck 5 is a lyophilized product consisting of Description Folate in human se…	Roche Diagnostics	2009	—

Also cleared against K092168: 5 other devices →

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 9 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K092168.

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. 2010, 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 Folate III 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 Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K094031 · printed Nov 4, 2026

Cite this page

510(k) Report. “K094031: Elecsys Folate Iii 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/K094031

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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