510(k) · Cleared
ClearedCA 125 II 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 Jan 12, 2001 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 12, 2001
- Review
- 21 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK003967 CA 125 II CalcheckRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 2 of its ownK102086 Elecsys CA 125 II Calcheck 5Roche Diagnostics · 2010
- Descendant · 2 generations on · 0 of its ownK143534 Elecsys CA-125 II assayRoche Professional Diagnostics · 2015
- Descendant · 2 generations on · 0 of its ownK132739 Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K102086Elecsys CA 125 II Calcheck 5Roche Diagnostics · 2010 · cites it directly2descendants
- K143534Elecsys CA-125 II assayRoche Professional Diagnostics · 2015 · 2 generations on0descendants
- K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003967 | CA 125 II Calcheck | Roche Diagnostics Corp. | 2001 | — |
| +1 | K102086 | Elecsys CA 125 II Calcheck 5 | Roche Diagnostics | 2010 | — |
| +2 | K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | 2015 | — |
| +2 | K132739 | Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102086 | Elecsys CA 125 II Calcheck 5 | 2010 | 2 |
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?
- Of its descendants, K102086 (Roche Diagnostics, 2010) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K003967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003967: CA 125 II Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003967
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026