(257 days)
The GenChem CO2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acidbase balance.
The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.
The provided text describes performance characteristics for the GenChem CO2 Acid Reagent, primarily focusing on its analytical performance rather than diagnostic accuracy against a ground truth dataset. Therefore, some of the requested information, particularly regarding expert consensus, MRMC studies, and ground truth establishment for a diagnostic algorithm, is not applicable or cannot be extracted from this document, as it describes a laboratory reagent for quantitative measurement of CO2.
Here's the information that can be extracted and presented according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Standard) | Reported Device Performance (GenChem CO2 Acid Reagent) |
|---|---|---|
| Precision/Reproducibility | Low %CV for various analyte levels | Serum 1: 3.2% CV (within run), 3.0% CV (total) |
| Serum 2: 1.4% CV (within run), 1.6% CV (total) | ||
| Serum 3: 1.7% CV (within run), 2.1% CV (total) | ||
| Linearity/Reportable Range | Excellent linearity (slope ~1, R² ~1) | Slope: 1.000, Intercept: 0.15, R²: 1.000 |
| Wide linear range | 0.0 to 40.0 mmol/L | |
| Sensitivity | Low detection limit | 0.255 mg/dL (calculated as 3 SD), below claimed limit of 5.0 mg/dL |
| Analytical Specificity | Minimal interference from common substances | No adverse effect from Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL) |
2. Sample size used for the test set and the data provenance
- Precision Study:
- Sample Size: 60 measurements for each of 3 control sera (2 measurements/day in triplicate over 10 days).
- Data Provenance: Not explicitly stated, but results are from tests performed on control sera.
- Patient Comparison Study:
- Sample Size: 80 serum samples and 80 plasma samples.
- Data Provenance: "Collected from adult patients." No specific country of origin is mentioned. These appear to be retrospective samples used for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes the performance of a reagent for quantitative CO2 measurement, not a diagnostic algorithm that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" for the patient comparison study would be the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®). No human experts are mentioned for establishing ground truth for the test set.
4. Adjudication method for the test set
Not applicable. The study involves quantitative measurements of CO2, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a chemical reagent, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a chemical reagent. Its performance is inherently "standalone" in generating a quantitative value, as it's not an algorithm that assists a human.
7. The type of ground truth used
- Precision, Linearity, Sensitivity, Analytical Specificity: These studies use controlled materials with known or expected values as their reference. The "ground truth" is the established chemical and analytical properties of the reference materials.
- Patient Comparison: The "ground truth" for comparison was the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®).
8. The sample size for the training set
Not applicable. This is a submission for a chemical reagent, not an AI-powered device that requires a training set. The "development" would involve chemical formulation and validation rather than algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this type of device.
§ 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.