510(k) · Cleared
ClearedElecsys CA 125 II 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 Nov 1, 2010 as substantially equivalent to K100810 (Roche Diagnostics, 2010) and 1 other predicate after a 98-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Nov 1, 2010
- Review
- 98 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. 2 later devices descend from it, 2 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 backK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
- This deviceK102086 Elecsys CA 125 II Calcheck 5Roche Diagnostics · 2010
- Descendant · cites it directly · 0 of its ownK143534 Elecsys CA-125 II assayRoche Professional Diagnostics · 2015
- Descendant · cites it directly · 0 of its ownK132739 Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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 | K100810 | Elecsys C-Peptide Calcheck 5 | Roche Diagnostics | 2010 | — |
| 0 (this device) | K102086 | Elecsys CA 125 II Calcheck 5 | Roche Diagnostics | 2010 | — |
| +1 | K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | 2015 | — |
| +1 | K132739 | Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K1008 10) and the Elecsys CA 125 II CalCheck (K003967). Device The Elecsys CA 125 11 CalCheck 5 is a lyophilized product consi… | 2010 |
| * | K003967 | CA 125 II CalcheckSummary page 1…similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K1008 10) and the Elecsys CA 125 II CalCheck (K003967). Device The Elecsys CA 125 11 CalCheck 5 is a lyophilized product consisting of Description equine serum in lev… | 2001 |
What descends from it? (2)
2 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 10 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K143534 (Roche Professional Diagnostics, 2015) has gone furthest, with 0 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 125 II 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 CA 125 II 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/K102086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102086: Elecsys CA 125 II Calcheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102086
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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