510(k) · Cleared
ClearedElecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JKR Radioimmunoassay, Calcitonin
Cleared on Dec 4, 2013 as substantially equivalent to K023304 (Diagnostic Products Corp., 2002) and 3 other predicates after an 86-day review. Its family tree reaches back 9 generations to 1993. 2 later devices descend from it.
- Decided
- Dec 4, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- JKR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K931172 (1993). 46 ancestors in all, the oldest K900779 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 5 generations between
- 3 generations backK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- 2 generations backK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- 1 generation backK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- This deviceK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · cites it directly · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · cites it directly · 0 of its ownK182012 ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018
Show all 9 generations
- Root · 9 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 8 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 7 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 6 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 5 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 4 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 3 generations backK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- 2 generations backK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- 1 generation backK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- This deviceK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
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 |
|---|---|---|---|---|---|
| −9 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −8 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −7 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −6 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −5 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −4 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −3 | K051517 | Elecsys Precicontrol Anemia | Roche Diagnostics Corp. | 2005 | — |
| −2 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| −1 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| 0 (this device) | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +1 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +1 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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.
Top candidate predicates for a new JKR device
- #1 K252431 Elecsys Calcitoninscore 13.9 · 10 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLSummary page 2…Predicate Device: 1) Assay: Siemens Immulite 1000 Calcitonin, Model LKCL (k023304) 2) Calibrator: Elecsys Vitamin D CalSet (kI 13546)… | 2002 |
| * | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys… | 2012 |
| * | K112528 | Elecsys T4 Calcheck 5Summary page 4…(k023304). e The Calcitonin CalSet with its predicate device (kI 13546). * The Calcitonin CaiCheck S its the predicate device (k 112528). * PreciControl Varia to its predicate device (kI 11506).… | 2011 |
| * | K111506 | Elecsys Precicontrol Varia 3Summary page 2…3) Control: Elecsys T4 CaiCheck 5 (ki 12528) 4) Control: Elecsys PreciControl Varia (kI 111506) Establishment For the Elecsys Calcitonin test system, the establishment registration Registration number for… | 2011 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 46 ancestors have a recall of any class.
- Of its descendants, K252431 (Roche Diagnostics GmbH, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JKR devicesJKR Radioimmunoassay, Calcitonin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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. Calcitonin CalSet is used for calibrating the quantitative…
Read the full statement (127 words)
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.
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Eiecsys and cobas e inmnunoiassay analyzers.
The Eleesys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the ealcironin assay range established by the Eiecsys and cobas e immunoassay analyzers.
The Elccsys PreciControl Varia is used for quality control of the Eleesys inimunoassays on Elecsys and cobas e immunoiassay analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132828
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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