510(k) · Cleared
ClearedElecys SHBG Calcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 20, 2003 as substantially equivalent to K020883 (Roche Diagnostics Corp., 2002) after a 79-day review. Its family tree reaches back 2 generations to 2000. 44 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 79 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001015 (2000). 44 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 1 generation backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- This deviceK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 42 of its ownK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- Descendant · 2 generations on · 32 of its ownK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
- Descendant · 2 generations on · 12 of its ownK051185 Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005
- Descendant · 3 generations on · 11 of its ownK101365 Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010
- Descendant · 4 generations on · 10 of its ownK122242 Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K040157Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004 · cites it directly42descendants
- K100810Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010 · 2 generations on32descendants
- K051185Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005 · 2 generations on12descendants
- K101365Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010 · 3 generations on11descendants
- K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −1 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| +1 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| +2 | K100810 | Elecsys C-Peptide Calcheck 5 | Roche Diagnostics | 2010 | — |
| +2 | K051185 | Elecsys CA 19-9 Calcheck | Roche Diagnostics Corp. | 2005 | — |
| +3 | K101365 | Elecsys CA 19-9 Calcheck 5 | Roche Diagnostics Corp. | 2010 | — |
| +4 | K122242 | Elecsys CA 15-3 II Calcheck 5 | Roche Diagnostics | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 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 |
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 |
|---|---|---|---|
| * | K020883 | Elecsys Probnp CalcheckSummary page 1…unassayed) Predicate The ElecsysB SHBG CalCheck is substantially equivalent to the currently device marketed ElecsysB proBNP CalCheck (K020883). Device The ElecsysB SHBG CalCheck is a lyophilized product manufactured using Description SHBG in human serum/… | 2002 |
What descends from it? (44)
See all 442 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040157 (Roche Diagnostics Corp., 2004) has gone furthest, with 42 descendants of its own.
- 1 other device also cites its predicate K020883.
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.
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?
EIecsysB SHBG CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined SHBG concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The ElecsysB SHBG CalCheck is intended for use in the verification of the calibration established by the ElecsysB SHBG reagent on Elecsys@ 1010/2010/MODULARANALYTICS E170 immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031698: Elecys SHBG Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031698
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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