510(k) · Cleared
ClearedCalcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scantibodies Laboratory, Inc. · JKR Radioimmunoassay, Calcitonin
Cleared on Aug 30, 2006 after a 177-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 30, 2006
- Review
- 177 days
- Class
- Class II
- Product code
- JKR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JKR devicesJKR Radioimmunoassay, Calcitonin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060578: Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060578
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026