# K191245: Yumizen C1200 ALP, Yumizen C1200 Albumin

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Aug 30, 2019 after 113 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K895880 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171080: ALP IFCC Gen.2, Roche Diagnostics Operations (Rdo) (2017) Summary page 6.
- K060434: Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical, Horiba Abx (2007) Summary page 6.

## Indications for use
Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Yumizen C 1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in huntan serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving prinrarily the liver or kidneys.

Source page: https://510kreport.com/device/K191245
Methodology: https://510kreport.com/methodology