510(k) · Cleared
ClearedCalcium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CJY Azo Dye, Calcium
Cleared on Nov 22, 2006 as substantially equivalent to K981578 (Abbott Laboratories, 1998) after a 58-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Nov 22, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- CJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850281 (1985). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K244042Calcium2Abbott Ireland · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850281 | Calcium | Boehringer Mannheim Corp. | 1985 | — |
| −1 | K981578 | CA | Abbott Laboratories | 1998 | — |
| 0 (this device) | K062855 | Calcium | Abbott Laboratories | 2006 | — |
| +1 | K244042 | Calcium2 | Abbott Ireland | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 CJY? 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 CJY device
- #1 K244042 Calcium2score 9.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K981578 | CASummary page 2…Page I Substantial Equivalence: The Calcium assay is substantially equivalent to the Abbott Calcium (K981578) on the AEROSET and ARCHITECT c8OOO System. Both assays yield similar Performance Characteristics. Similarities:… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K244042 | Calcium2 | 2025 | 0 |
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 21 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K244042 (Abbott Ireland, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJY
Too few CJY 510(k)s in any year since 2007 to give a median.
Recalls per year · CJY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJY
59in 2025
MAUDE reports naming product code CJY, 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 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 4 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 2 | 21 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A calcium test system is a device intended to measure the total calcium level in serum,
plasma, and urine. Calcium measurements are used in the diagnosis and treatment of
parathyroid disease, a variety of bone diseases, chronic renal disease and tetany
(intermittent muscular contractions or spasms).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062855: Calcium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062855
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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