510(k) · Cleared
ClearedElecsys CA 19-9 Calcheck 5
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 Oct 5, 2010 as substantially equivalent to K100810 (Roche Diagnostics, 2010) and 1 other predicate after a 141-day review. Its family tree reaches back 5 generations to 2000. 11 later devices descend from it.
- Decided
- Oct 5, 2010
- Review
- 141 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001015 (2000). 6 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 4 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 3 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 2 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 1 generation backK051185 Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005
- This deviceK101365 Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010
- Descendant · cites it directly · 10 of its ownK122242 Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012
- Descendant · 2 generations on · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · 3 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
- Descendant · 4 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
- Descendant · 5 generations on · 0 of its ownK230994 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012 · cites it directly10descendants
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 2 generations on8descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 3 generations on2descendants
- K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 4 generations on1descendant
- K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −4 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −3 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −2 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −1 | K051185 | Elecsys CA 19-9 Calcheck | Roche Diagnostics Corp. | 2005 | — |
| 0 (this device) | K101365 | Elecsys CA 19-9 Calcheck 5 | Roche Diagnostics Corp. | 2010 | — |
| +1 | K122242 | Elecsys CA 15-3 II Calcheck 5 | Roche Diagnostics | 2012 | — |
| +2 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +3 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
| +4 | K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022 | — |
| +5 | K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K100810 | Elecsys C-Peptide Calcheck 5Summary page 1…ducts device in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K 100810) and CA 19- 9 CalCheck (K051185). Device The Elecsys CA 19-9 CalCheck 5 is a lyophilized product con… | 2010 |
| * | K051185 | Elecsys CA 19-9 CalcheckSummary page 1…intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K 100810) and CA 19- 9 CalCheck (K051185). Device The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of Description human CA 19-9 in huma… | 2005 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122242 | Elecsys CA 15-3 II Calcheck 5 | 2012 | 10 |
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 10 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122242 (Roche Diagnostics, 2012) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K100810.
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. 2010, 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 CA 19-9 CaiCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101365: Elecsys CA 19-9 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/K101365
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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