510(k) · Cleared
ClearedElecsys Calcitonin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics GmbH · JKR Radioimmunoassay, Calcitonin
Cleared on Apr 24, 2026 as substantially equivalent to K132828 (Roche Diagnostics, 2013) after a 266-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Apr 24, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- JKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931172 (1993). 47 ancestors in all, the oldest K900779 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 6 generations between
- 3 generations backK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- 2 generations backK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- 1 generation backK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- This deviceK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
Show all 10 generations
- Root · 10 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 9 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 8 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 7 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 6 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 5 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 4 generations backK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- 3 generations backK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- 2 generations backK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- 1 generation backK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- This deviceK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −9 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −8 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −7 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −6 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −5 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −4 | K051517 | Elecsys Precicontrol Anemia | Roche Diagnostics Corp. | 2005 | — |
| −3 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| −2 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| −1 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| 0 (this device) | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 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 JKR? 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 |
|---|---|---|---|
| * | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Summary page 5…e: Radioimmunoassay, Calcitonin Product Code: JKR Regulation Number: 21 CFR 862.1140 Predicate Device: Elecsys Calcitonin (K132828) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Roc… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 47 ancestors have a recall of any class.
- 1 other device also cites its predicate K132828.
How does its category compare?
All JKR devicesJKR Radioimmunoassay, Calcitonin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JKR
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JKR
Too few JKR 510(k)s in any year since 2007 to give a median.
Recalls per year · JKR
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKR
1in 2025
MAUDE reports naming product code JKR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Calcitonin immunoassay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252431: Elecsys Calcitonin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252431
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026