(39 days)
The Carbon Dioxide (CO2) assay is used for the quantitation of carbon dioxide in human serum or plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Carbon Dioxide (CO2) is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. The Carbon Dioxide assay is a clinical chemistry assay in which 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 dehydorgenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). The resulting decrease in absorbance at 380 nm is proportional to the CO2 content of the sample.
The provided text describes a 510(k) submission for the Abbott Laboratories Carbon Dioxide (CO2) assay. The study presented is a comparative performance study against a predicate device, not a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The data is about an in-vitro diagnostic method, which does not involve human readers or AI in the traditional sense. Therefore, many of the requested sections about human performance, AI, and ground truth establishment from expert consensus are not applicable.
Here's the information that can be extracted and presented based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with Predicate Device: | |
| Correlation Coefficient | 0.9691 |
| Slope | 0.991 |
| Y-intercept | 2.779 mEq/L |
| Precision: | |
| Total %CV (Level 1/Panel 111 control) | 3.6% |
| Total %CV (Level 2/Panel 112 control) | 3.9% |
| Linearity: | Up to 40.0 mEq/L |
| Limit of Quantitation (Sensitivity): | 4.0 mEq/L |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the comparative performance study.
- Data Provenance: Not explicitly stated, however, the study was conducted using the ALCYON™ Analyzer and compared against the Roche Cobas Mira Plus Automated Chemistry System. The nature of in vitro diagnostic assays implies laboratory samples, typically from human serum or plasma. It is a prospective study as it was conducted to demonstrate performance for the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an in vitro diagnostic assay, the "ground truth" is typically established by reference methods or validated predicate devices rather than expert consensus on images or similar data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to expert review of ambiguous cases, which is not relevant for this type of analytical performance study.
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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 study is for an in vitro diagnostic assay, not a device involving human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided study describes the performance of the Carbon Dioxide assay method itself, which operates as a standalone diagnostic test without human-in-the-loop performance in the AI context. The study is a standalone performance assessment of the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this study was established by comparison to a legally marketed predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Carbon Dioxide assay (K844987). This means the predicate device's results served as the reference for determining the substantial equivalence of the new device's performance.
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The sample size for the training set: Not applicable. This is an analytical performance study for an in vitro diagnostic assay, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable. (See #7).
§ 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.