510(k) · Cleared
ClearedCalcium2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Ireland · CJY Azo Dye, Calcium
Cleared on Feb 10, 2025 as substantially equivalent to K062855 (Abbott Laboratories, 2006) after a 42-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Feb 10, 2025
- Review
- 42 days
- Class
- Class II
- Product code
- CJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K850281 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
- 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 |
|---|---|---|---|
| * | K062855 | CalciumSummary page 6…Name: Calcium Test System Regulation Number: 21 CFR §862.1145 Product Code: CJY III. Predicate Device Abbott Clinical Chemistry Architect/Aeroset Calcium; k062855 IV. Description of Device A. Principles of the Procedure The Calcium2 assay is an automated clinical chemistry ass… | 2006 |
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 40 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.
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/K244042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244042: Calcium2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244042
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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