(212 days)
For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
This in vitro diagnostic device is intended for Rx Only.
The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.
The provided text describes the acceptance criteria and performance of the LIQUID CO2-2 (LCO2-2) device, which is an in vitro diagnostic for quantitative determination of Carbon Dioxide in serum and plasma.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | (Not explicitly stated as a single numerical criterion, but evaluated consistent with CLSI EP5-A2 guidelines) | QC Level 3: SD 0.79, CV 4.5% |
| QC Level 2: SD 0.63, CV 5.5% | ||
| SP Level 1: SD 0.75, CV 6.7% | ||
| SP Level 2: SD 0.93, CV 5.0% | ||
| SP Level 3: SD 1.33, CV 3.8% | ||
| Linearity/Reportable Range | Deviation from linearity |
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.