510(k) · Cleared
ClearedOlympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · CJY Azo Dye, Calcium
Cleared on Oct 5, 2006 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 5, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- CJY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK061575 Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117Olympus America, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
- Descendant · cites it directly · 1 of its ownK200898 Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas…Medicon Hellas S.A · 2021
- Descendant · 2 generations on · 0 of its ownK251157 Core MetabolicTruvian Health · 2026
- Descendant · 2 generations on · 0 of its ownK191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019
- Descendant · 2 generations on · 0 of its ownK151113 ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup · 2015
Most influential descendants
Showing 5 of 5 · See all- K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · cites it directly2descendants
- K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…Medicon Hellas S.A · 2021 · cites it directly1descendant
- K251157Core MetabolicTruvian Health · 2026 · 2 generations on0descendants
- K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019 · 2 generations on0descendants
- K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061575 | Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117 | Olympus America, Inc. | 2006 | — |
| +1 | K123171 | Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical… | Horiba Abx Sas | 2013 | — |
| +1 | K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine… | Medicon Hellas S.A | 2021 | — |
| +2 | K251157 | Core Metabolic | Truvian Health | 2026 | — |
| +2 | K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Horiba Abx Sas | 2019 | — |
| +2 | K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K123171 (Horiba Abx Sas, 2013) has gone furthest, with 2 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?
OLYMPUS System reagent for the quantitative determination of calcium concentrations
in human serum, plasma and urine on OLYMPUS analyzers.
Measurement of calcium is 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 510(k) statement.
https://510kreport.com/device/K061575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061575: Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061575
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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