(29 days)
The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3) concentration in human serum and 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.
The COBAS Integra Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 409 nm is proportional to the concentration of bicarbonate in the sample.
This document describes the COBAS Integra Bicarbonate liquid, an in vitro diagnostic reagent system. The information provided focuses on the regulatory aspects and intended use of the device, rather than a detailed study proving its performance against specific acceptance criteria in the format requested.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- Focus on Substantial Equivalence: The document is primarily a 510(k) summary, aiming to establish "substantial equivalence" to a predicate device (COBAS Integra Carbon Dioxide Assay). This means the focus is on demonstrating that the new device is as safe and effective as a legally marketed one, rather than presenting a comprehensive study with pre-defined acceptance criteria and raw performance data.
- Lack of Performance Data: The summary emphasizes similarities in intended use, method, sample type, and measuring range. While it mentions "Expected values," these are clinical reference ranges, not performance metrics.
- No Details on Study Design: There's no information about specific studies, sample sizes, ground truth establishment, expert involvement, or adjudication methods for this device.
Therefore, many of the requested fields cannot be accurately populated from the provided text.
However, based on the context of a 510(k) submission for an in vitro diagnostic (IVD) reagent, we can infer some general acceptance criteria and potential study types, though specific numbers are absent.
Inferred Acceptance Criteria (Typical for IVDs) and Reported Device Performance (as much as can be extracted/inferred):
| Acceptance Criteria Category (Inferred for IVD Reagents) | Inferred/Reported Device Performance |
|---|---|
| Reproducibility/Precision: (e.g., CV% within limits) | Not explicitly stated in terms of a specific study or numeric criteria. The claim of "substantial equivalence" to the predicate device (COBAS Integra Carbon Dioxide Assay, K980996) implies that the new device's precision characteristics are comparable and acceptable. |
| Accuracy/Bias: (e.g., agreement with a reference method) | Not explicitly stated in terms of a specific study or numeric criteria. Again, "substantial equivalence" suggests comparable accuracy to the predicate. The method is enzymatic and colorimetric, implying that its fundamental mechanism aims for accurate measurement. |
| Measuring Range: | Reported Performance: 0 - 50 mmol/L. This is stated as "Same" as the predicate device, indicating it meets the established range. |
| Applicable Sample Types: | Reported Performance: Human Serum and Plasma. This is stated as "Same" as the predicate device, confirming it meets this criteria. |
| Stability (Reagent and Calibrator): | Not explicitly stated. For an IVD reagent system, stability (onboard, open vial, shelf life) would be critical acceptance criteria, though no specific data is presented here. Substantial equivalence would imply similar or improved stability profile compared to the predicate. |
| Interferences: (e.g., from common substances) | Not explicitly stated. IVDs typically have acceptance criteria for known interferents (e.g., hemolysis, lipemia, icterus, common medications). Substantial equivalence would suggest the interference profile is acceptable and comparable to the predicate. |
| Expected/Reference Values: | Reported Performance: 22 - 29 mmol/L for anaerobic venous plasma or serum. The predicate device's expected range was 23 - 29 mmol/L. This slight difference might be due to updated reference populations or method equivalency, but it falls within a clinically acceptable range for bicarbonate, implying it meets the expectation for normal physiological values. |
| Intended Use: | Reported Performance: "The cassette COBAS Integra Bicarbonate liquid (CO2-L) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate ($HCO_3^-$) concentration in human serum and plasma." This aligns with the specified intended use and is demonstrated through the substantial equivalence argument, assuming the performance (accuracy, precision, range) supports this claim. The FDA's clearance confirms this intended use is supported. |
Information Not Available in the Provided Text:
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an IVD reagent summary. The "ground truth" for chemical measurements typically relies on reference methods or gravimetric/volumetric standards, not expert consensus.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for an IVD reagent summary.
- 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 an IVD reagent, not an AI-assisted diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a biochemical assay. Its "performance" is inherently standalone.
- The type of ground truth used: For an IVD reagent measuring a chemical concentration, the ground truth would typically be established by a primary reference measurement procedure or certified reference materials traceable to higher-order standards. The document does not specify which reference method was used for validation.
- The sample size for the training set: Not applicable in the context of an IVD reagent assay. There is no AI model being trained here.
- How the ground truth for the training set was established: Not applicable.
Summary of what can be extracted/inferred:
- Device Type: In Vitro Diagnostic (IVD) Reagent System
- Purpose: Quantitative determination of bicarbonate ($HCO_3^-$) concentration in human serum and plasma.
- Method: Enzymatic, colorimetric test.
- Predicate Device: COBAS Integra Carbon Dioxide Assay (K980996).
- Key "Performance" similarities to predicate (implying acceptance): Same method, sample type (Human Serum and Plasma), and measuring range (0-50 mmol/L).
- Minor difference (but within clinical acceptance): Expected values for anaerobic venous plasma or serum - 22-29 mmol/L for the new device vs. 23-29 mmol/L for the predicate.
- Study Type: The document is a 510(k) summary, which relies on demonstrating substantial equivalence. It implies that performance studies (accuracy, precision, interference, linearity, stability) were conducted to support this claim, but the details of these studies are not provided in this specific excerpt.
§ 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.