# K023875: Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 10, 2002 after 19 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812030 (1981). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812030: Kodak Ektachem Clin. Chem. Slides (Alb), Eastman Kodak Company (1981) Summary page 3.
- K922072: Kodak Ektachem 250 Analyer, Eastman Kodak Company (1992) Summary page 2.

## Most influential descendants
- K191316: VITROS XT Chemistry Products ALB-TP Slides (2019), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0294-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma. VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Source page: https://510kreport.com/device/K023875
Methodology: https://510kreport.com/methodology