Total CO2 Reagent Set
by American Research Products Co.
510(k) K832071
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832071 | Date11 Aug 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CIE
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1160
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Total CO₂ Reagent Set is a volumetric/manometric reagent system designed for measuring total carbon dioxide levels in clinical chemistry. It falls under the classification of volumetric/manometric devices and is specifically intended for use in laboratory settings to quantify CO₂ concentrations in blood or other biological samples. This measurement is critical for assessing acid-base balance and metabolic function in patients.
The reagent set is supplied as a single-use product for in vitro diagnostic use, adhering to FDA 510(k) clearance under product code CIE. It is intended for use in clinical chemistry laboratories and requires proper handling and storage as per manufacturer guidelines. The device was cleared under the Traditional 510(k) pathway with a decision date of August 11, 1983, and is classified as a Class II medical device. No additional regulatory status beyond the stated FDA clearance is implied.
Other devices from American Research Products Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Total CO₂ Reagent Set used for in clinical settings?
The Total CO₂ Reagent Set is designed specifically for measuring total carbon dioxide levels in blood or other biological samples within clinical chemistry laboratories. Accurate CO₂ quantification is vital for evaluating a patient’s acid-base balance and metabolic function, helping clinicians diagnose and monitor conditions like respiratory disorders, metabolic acidosis, or alkalosis.
How is the Total CO₂ Reagent Set supplied, and is it reusable?
The Total CO₂ Reagent Set is supplied as a single-use product for in vitro diagnostic use. It is not intended for reuse, as single-use devices are engineered for one-time application to ensure accuracy, sterility, and patient safety. Discarding after use prevents cross-contamination and maintains reliable test results.
What storage or handling requirements does this reagent set have?
Like all single-use diagnostic reagents, the Total CO₂ Reagent Set must be stored according to the manufacturer’s guidelines to preserve its integrity and performance. Typically, this includes keeping it in a cool, dry place (e.g., 2–8°C if refrigerated) and protecting it from light or moisture until use. Check the packaging for specific storage instructions, as improper conditions could compromise reagent stability or test accuracy.
Is this device regulated by the FDA, and what classification does it fall under?
Yes, the Total CO₂ Reagent Set is cleared by the FDA under the 510(k) pathway and classified as a Class II medical device. It was granted clearance in 1983 under product code CIE (Clinical Chemistry) and is intended for use in laboratory settings. The clearance confirms it meets regulatory standards for safety and effectiveness as a volumetric/manometric device.
Are there different models or sizes available for this reagent set?
The provided data does not specify multiple models or sizes for the Total CO₂ Reagent Set. It is described as a single reagent system designed for volumetric/manometric CO₂ measurement, implying a standardized configuration for clinical chemistry applications. For variations or custom options, consult the manufacturer’s product documentation or support team.