Carbon Dioxide
by Abbott Laboratories 510(k)
Active
510(k) K060295
Overview
This device is an enzymatic analyzer for measuring carbon dioxide levels in clinical chemistry. It quantifies dissolved CO₂ in serum or plasma samples using enzymatic reactions, providing precise analytical results for diagnostic purposes.
The Carbon Dioxide Enzymatic Analyzer is intended for use in clinical laboratories as a single-use or reusable instrument, depending on model configuration. Supplied as a reagent-based system, it adheres to FDA 510(k) clearance under device classification II (KHS product code) and regulatory requirements outlined in 21 CFR 862.1160. Multiple reference codes (e.g., 3016438761, 1000305840) identify compatible reagent kits for accurate measurement.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060295 | Date4 May 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0575-2020
Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.
Specification
- 510(k) Number
- FDA Product Code
- KHS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1160
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical setting is this device designed for, and how does it differ from manual testing methods?
This device is designed for use in clinical laboratories to measure dissolved carbon dioxide levels in serum or plasma samples. Unlike manual testing methods, it uses an enzymatic analyzer system to automate the measurement process, providing precise and standardized results through enzymatic reactions. This reduces human error and variability while improving efficiency in diagnostic workflows.
Is this device single-use or reusable, and what factors influence that choice?
The device can be used as either single-use or reusable, depending on the specific model configuration. Reusable models are designed for repeated use in laboratory settings, while single-use variants may be optimized for convenience in environments where contamination risk or turnaround time is a concern. The manufacturer’s instructions for each model clarify usage guidelines.
What types of reagent kits are compatible with this analyzer, and how do I ensure accurate measurements?
This analyzer is compatible with multiple reagent kits, identified by reference codes such as 3016438761, 1000305840, and others listed in the regulatory data. To ensure accurate measurements, always use the manufacturer-specified reagent kits designed for this system. Using incompatible reagents could lead to inaccurate results, so verify compatibility with Abbott Laboratories’ documentation or support.
How should this device be stored, and are there any special handling requirements for the reagents?
While the device itself is not detailed for storage conditions in the provided data, reagent kits for enzymatic analyzers typically require cool, dry storage (often between 2°C–8°C) to maintain stability. Always follow the storage instructions provided with each reagent kit to prevent degradation. Improper storage can compromise accuracy and device performance.