510(k) · Cleared
ClearedRoche Diagnostics Elecsys Prolactin II Calcheck
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 28, 2005 as substantially equivalent to K970147 (Boehringer Mannheim Corp., 1997) after a 28-day review. Its family tree reaches back 2 generations to 1992. 5 later devices descend from it.
- Decided
- Nov 28, 2005
- Review
- 28 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924863 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK924863 Aia-Pack FSH Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 1 generation backK970147 Elecsys Calcheck ProlactinBoehringer Mannheim Corp. · 1997
- This deviceK053059 Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics · 2005
- Descendant · cites it directly · 4 of its ownK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 1 of its ownK111335 ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221…Tosoh Bioscience, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK223867 Ids Acth IIImmunodiagnostic Systems Limited · 2023
- Descendant · 3 generations on · 0 of its ownK143296 AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK131662 Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006 · cites it directly4descendants
- K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc. · 2011 · 2 generations on1descendant
- K223867Ids Acth IIImmunodiagnostic Systems Limited · 2023 · 2 generations on0descendants
- K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014 · 3 generations on0descendants
- K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924863 | Aia-Pack FSH Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −1 | K970147 | Elecsys Calcheck Prolactin | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K053059 | Roche Diagnostics Elecsys Prolactin II Calcheck | Roche Diagnostics | 2005 | — |
| +1 | K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | Roche Diagnostics Corp. | 2006 | — |
| +2 | K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 | Tosoh Bioscience, Inc. | 2011 | 2 |
| +2 | K223867 | Ids Acth II | Immunodiagnostic Systems Limited | 2023 | — |
| +3 | K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | 2014 | — |
| +2 | K131662 | Immulite 2000 Acth Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K970147 | Elecsys Calcheck ProlactinSummary page 2…CalCheck is equivalent to other devices legally device marketed in the United States. We claim equivalence to the Elecsys Prolactin CalCheck (K970147). Device The table below illustrates the similarities between the Elecsys Prolactin comparison CalCheck (K97014… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | 2006 | 4 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060585 (Roche Diagnostics Corp., 2006) has gone furthest, with 4 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 | — |
What is it indicated for?
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on
Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053059: Roche Diagnostics Elecsys Prolactin 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/K053059
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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