(87 days)
The Carbon Dioxide test system, reagent and calibrator, is a device intended to measurc bicarbonate/carbon dioxide in plasma, and serum. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentia!ly serious disorders associated with changes in body acid-base balance.
Carbon Dioxide is an in vitro diagnostic assay for the quantitative analysis of CO2 in human serum or plasma. Carbon dioxide, as bicarbonate (HCO3), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH) analog. The resulting decrease in absorbance at 404 nm is proportional to the CO2 content in the sample.
Here's a summary of the acceptance criteria and study detailed in the provided 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Abbott Carbon Dioxide Assay) |
|---|---|---|
| Method Comparison (vs. Hitachi 717 CO2L) | ||
| AEROSET System | Correlation Coefficient: "similar" | 0.994 |
| Slope: "similar" | 0.99 | |
| Y-intercept: "similar" | -0.20 mEq/L | |
| ARCHITECT c8000 System | Correlation Coefficient: "similar" | 0.9893 |
| Slope: "similar" | 0.98 | |
| Y-intercept: "similar" | -0.75 mEq/L | |
| Method Comparison (AEROSET vs. ARCHITECT c8000) | ||
| ARCHITECT c8000 System | Correlation Coefficient: "similar" | 0.995 |
| Slope: "similar" | 0.98 | |
| Y-intercept: "similar" | -0.55 mEq/L | |
| Precision (%CV) | ||
| AEROSET System | Level 1: Not specified, but comparable to predicate | Level 1: 2.0% |
| Level 2: Not specified, but comparable to predicate | Level 2: 2.4% | |
| ARCHITECT c8000 System | Level 1: Not specified, but comparable to predicate | Level 1: 2.1% |
| Level 2: Not specified, but comparable to predicate | Level 2: 2.5% | |
| Linearity Range | Not specified, but comparable to predicate | 5 to 50 mEq/L |
| Functional Sensitivity (Limit of Quantitation) | Not specified, but comparable to predicate | 4 mg/dL |
| Limit of Detection (LOD) | Not specified, but comparable to predicate | 2 mEq/L |
Note: The acceptance criteria for this 510(k) submission are implied by the claim of "substantial equivalence" to the predicate device (Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer) and the phrasing "Both assays yield similar Performance Characteristics." Specific numerical thresholds for "similar" are not explicitly stated for all parameters, but the presented results are considered acceptable for demonstrating substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the method comparison or precision studies. It mentions "Comparative performance studies were conducted" but does not provide the number of samples or subjects included.
Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This submission is for an in vitro diagnostic assay, which measures a quantifiable analyte (carbon dioxide) in human serum or plasma. Therefore, the concept of "experts" establishing ground truth as typically seen in image analysis or diagnostic interpretation studies (e.g., radiologists, pathologists) does not directly apply here. The "ground truth" for method comparison is established by the performance of the legally marketed predicate device (Hitachi 717 Analyzer).
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic assay, adjudication in the sense of reconciling differing expert opinions on a diagnostic image or case is not relevant. The "truth" is based on the measurement provided by the reference method (predicate device).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretation where human readers are involved. This submission is for an automated in vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented is for the standalone performance of the Abbott Carbon Dioxide assay on the AEROSET and ARCHITECT c8000 Systems. These are automated systems, and the performance characteristics reported (correlation, precision, linearity, limits) are intrinsic to the device's measurement capabilities without direct human intervention in the analysis process beyond sample loading and general operation.
7. The Type of Ground Truth Used
The ground truth for the comparative performance studies was established by the legally marketed predicate device, the Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the new device's measurements are compared against an already approved and accepted method.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. For an in vitro diagnostic chemical assay, the development process typically involves reagent formulation, optimization, and validation, rather than machine learning model "training" with a distinct dataset. The performance data presented are for the validation of the final device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, information on a "training set" for a machine learning model is not provided, nor is it typically relevant for this type of in vitro diagnostic assay. The ground truth for the validation and substantial equivalence assessment was the predicate device's performance.
§ 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.