# K120765: Vitros Chemistry Products ECO2 Slides

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 24, 2012 after 225 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- 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 K001133 (2000). 1 ancestor in all.
2 later devices descend 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)
- K001133: Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2, Ortho-Clinical Diagnostics, Inc. (2000)

## Most influential descendants
- K182072: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (2018), 1 descendant of its own
- K190520: VITROS XT Chemistry Products GLU-Ca Slides (2019), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0312-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products ECO 2 Slides quantitatively measure total carbon dioxide (C0 2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K120765
Methodology: https://510kreport.com/methodology