# K190326: VITROS XT Chemistry Products UREA-CREA Slides

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Mar 14, 2019 after 29 days
- Product code: CDN (Urease, Photometric, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001310 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001885: Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1, Ortho-Clinical Diagnostics, Inc. (2000) Summary page 4.
- K182063: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System, Ortho-Clinical Diagnostics, Inc. (2018) Summary page 4.

## Indications for use
For in vitro diagnostic use only The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea concentration, reported either as urea nitrogen or as urea (UREA), in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases The CREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures creatinine (CREA) concentration in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K190326
Methodology: https://510kreport.com/methodology