# K071340: Carbon Dioxide (CO2), Scal, Nortrol and Abtrol

- Pathway: 510(k) (Traditional)
- Applicant: Thermofisher Scientific OY
- Decided: Oct 5, 2007 after 144 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: 5 generations back to K842280 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid, Roche Diagnostics Corp. (2003) Summary page 3.

## Indications for use
Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer. Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy. For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Source page: https://510kreport.com/device/K071340
Methodology: https://510kreport.com/methodology