510(k) · Cleared
ClearedCalcium Gen. 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CHW Titrimetric With Edta And Indicator, Calcium
Cleared on May 8, 2012 as substantially equivalent to K921661 (Boehringer Mannheim Corp., 1992) after a 161-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 8, 2012
- Review
- 161 days
- Class
- Class II
- Product code
- CHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921661 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921661 Boehringer Mannheim/ Hitachi 911 AnalyzerBoehringer Mannheim Corp. · 1992 · Recalled
- This deviceK113521 Calcium Gen. 2Roche Diagnostics · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921661 | Boehringer Mannheim/ Hitachi 911 Analyzer | Boehringer Mannheim Corp. | 1992 | 1 |
| 0 (this device) | K113521 | Calcium Gen. 2 | Roche Diagnostics | 2012 | — |
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 CHW? 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 |
|---|---|---|---|
| * | K921661 | Boehringer Mannheim/ Hitachi 911 AnalyzerSummary page 2…achi cobas c systems. Predicate Roche claims substantial equivalence to the currently marketed device Calcium test system cleared in K921661. Substantial The following table compares the features of the draft device with the equivalence pre… | 1992 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K921661.
How does its category compare?
All CHW devicesCHW Titrimetric With Edta And Indicator, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CHW
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CHW
Too few CHW 510(k)s in any year since 2007 to give a median.
Recalls per year · CHW
No recall names CHW since 2007.
Adverse event reports per year · CHW
22in 2025
MAUDE reports naming product code CHW, 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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Calcium Gen.2 assay is an in vitro diagnostics reagent system intended for the quantitative determination of calcium in human serum, plasma, and urine on Roche/Hitachi cobas c systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
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/K113521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113521: Calcium Gen. 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113521
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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