510(k) · Cleared
ClearedElecsys Progesterone III Cal Check 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 May 1, 2015 as substantially equivalent to K142127 (Roche Diagnostics, 2014) after a 22-day review. Its family tree reaches back 3 generations to 2010. 2 later devices descend from it.
- Decided
- May 1, 2015
- Review
- 22 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K093582 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK093582 Elecsys CK-MB Calcheck 5Roche Diagnostics · 2010
- 2 generations backK133284 Elecsys CK-MB Calcheck 5Roche Diagnostics · 2013
- 1 generation backK142127 Elecsys Estradiol Iii Calcheck 5Roche Diagnostics · 2014
- This deviceK150955 Elecsys Progesterone III Cal Check 5Roche Diagnostics · 2015
- Descendant · cites it directly · 0 of its ownK162173 Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
- Descendant · cites it directly · 0 of its ownK160729 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics · 2016 · Recalled
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 |
|---|---|---|---|---|---|
| −3 | K093582 | Elecsys CK-MB Calcheck 5 | Roche Diagnostics | 2010 | — |
| −2 | K133284 | Elecsys CK-MB Calcheck 5 | Roche Diagnostics | 2013 | — |
| −1 | K142127 | Elecsys Estradiol Iii Calcheck 5 | Roche Diagnostics | 2014 | — |
| 0 (this device) | K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | 2015 | — |
| +1 | K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | 2017 | — |
| +1 | K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | Roche Diagnostics | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K142127 | Elecsys Estradiol Iii Calcheck 5 Our reading of the summary gave K142147, FDA’s number for Eeva System (Auxogyn, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Elecsys Estradiol III CalCheck 5”. | 2014 |
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 5 years and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162173 (Roche Diagnostics, 2017) has gone furthest, with 0 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. 2015, 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 Progesterone III 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 Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150955: Elecsys Progesterone III Cal Check 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150955
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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