# K093611: Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002;

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Apr 15, 2010 after 143 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K984303 (1999). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802376: Kodak Ekta-Chem Clinical Chem. Slides, Eastman Kodak Company (1980) Summary page 1.
- K091861: Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model 195 7927, Ortho-Clinical Diagnostics, Inc. (2009) Summary page 1.
- K001133: Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2, Ortho-Clinical Diagnostics, Inc. (2000)

## Cited in the summary but kept off the family tree
- K810257: Vessel Tips, Sizes 13-18, Quinton, Inc. (1981). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
VITROS Chemistry Products CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Total carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K093611
Methodology: https://510kreport.com/methodology