# K191396: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Jul 26, 2019 after 63 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
Longest line of descent: 5 generations back to K933930 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont, Horiba Abx Sas (2013) Summary page 6.
- K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control, Horiba Abx Sas (2012) Summary page 6.

## Indications for use
Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. 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). Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K191396
Methodology: https://510kreport.com/methodology