# K001885: Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jul 20, 2000 after 29 days
- Product code: CDN (Urease, Photometric, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023876: Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1 (2002), 2 descendants of its own
- K072440: Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208) (2007), 1 descendant of its own
- K190520: VITROS XT Chemistry Products GLU-Ca Slides (2019), 0 descendants of its own
- K190326: VITROS XT Chemistry Products UREA-CREA Slides (2019), 0 descendants of its own

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1837-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the
- Jun 12, 2013 · Class II · Z-0301-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Source page: https://510kreport.com/device/K001885
Methodology: https://510kreport.com/methodology