# K061575: Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Oct 5, 2006 after 120 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (2021), 1 descendant of its own
- K251157: Core Metabolic (2026), 0 descendants of its own
- K191396: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (2019), 0 descendants of its own
- K151113: ELITech Clinical Systems CALCIUM ARSENAZO (2015), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K061575
Methodology: https://510kreport.com/methodology