# K193001: Albumin BCP

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Dec 19, 2019 after 52 days
- Product code: CJW (Bromcresol Purple Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K132664 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132664: Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 5.

## Indications for use
The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The assay is intended for professional use only. For In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K193001
Methodology: https://510kreport.com/methodology