510(k) · Cleared
Recalled · Class II · 2022Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915 (70 ML Fill)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CJY Azo Dye, Calcium
Cleared on Apr 2, 2009 as substantially equivalent to K991576 (Bayer Corp., 1999) after a 136-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 2, 2009
- Review
- 136 days
- Class
- Class II
- Product code
- CJY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991576 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK991576 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- This deviceK083386 Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML…Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK182042 Randox Calcium (Ca)Randox Laboratories, Ltd. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K182042Randox Calcium (Ca)Randox Laboratories, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 3 |
| 0 (this device) | K083386 | Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N… | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 1…. Panel: Clinical Chemistry F. Predicate Device: ADVIA Chemistry Calcium_2 Method is substantially equivalent to the ADVIA Chemistry 1650 Calcium method cleared under K991576. G. Device Description: Summary and Explanation: the Calcium_2 (CA 2) method is based on the work of Michaylova and Illko… | 1999 |
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 |
|---|---|---|---|
| K182042 | Randox Calcium (Ca) | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2022 | Class II | Z-0928-2022 | Device Design | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
For in vitro diagnostic use in the quantitative determination of calcium in human serum,
plasma, and urine on the ADVIA Chemistry systems. Such measurements are used in the
diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal
failure, and tetany
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083386: Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915 (70 ML Fill).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083386
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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