# K191316: VITROS XT Chemistry Products ALB-TP Slides

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 7, 2019 after 23 days
- Product code: CIX (Bromcresol Green 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: 2 generations back to K812030 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023875: Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4, Ortho-Clinical Diagnostics, Inc. (2002) Summary page 4.

## Indications for use
For in vitro diagnostic use only The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Source page: https://510kreport.com/device/K191316
Methodology: https://510kreport.com/methodology