510(k) · Cleared
ClearedElecsys SHBG Calcheck 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jun 9, 2011 as substantially equivalent to K031698 (Roche Diagnostics Corp., 2003) after a 27-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jun 9, 2011
- Review
- 27 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001015 (2000). No later device cites it as a predicate yet.
- 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 deviceK111349 Elecsys SHBG Calcheck 5Roche Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K031698 | Elecys SHBG CalcheckSummary page 1…nt to other products device in commercial distribution intended for similar use. We claim equivalency to the currently marketed SHBG CalCheck (K031698). Device The Elecsys SHBG CalCheck 5 is a lyophilized product consisting of SHBG Description in human and equine… | 2003 |
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 11 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K031698.
How does its category compare?
All JJX devicesJJX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 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 SHBG 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 SHBG reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111349: Elecsys SHBG 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/K111349
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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