(51 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure total CO2 from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with respiratory and metabolic disorders associated with acid-base imbalance.
CARESIDE™ CO2 cartridges are used with the CARESIDE Analyzer™ to measure total CO2 in whole blood, serum or plasma specimens. The CARESIDE™ CO2 cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of total CO2 The film cartridge (patent pending) contains all reagents necessary to measure total CO2.
Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ CO2 device, based on the provided text:
CARESIDE™ CO2 Device: Acceptance Criteria and Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Predicate Device Specification (Vitros CO2 DT Slides) | CARESIDE™ CO2 Performance (as reported) |
|---|---|---|
| Detection Limit | 5 mmol/L | 5 mmol/L |
| Reportable Range | 5 to 50 mmol/L | 5 to 40 mmol/L |
| Accuracy | Not provided | Mean recovery 101% |
| Precision | Total CV, 22 mmol/L, 6.6% | Total CV, 19 mmol/L, 6.6% |
| Method Comparison | Not specified (this is the comparison equation) | CARESIDE™ = 1.06 (Vitros CO2 DT) - 1.94 mmol/L, r = 0.97 |
| Linearity | Not provided | Linearity yielded slope and correlation coefficient within acceptable limits. |
| Interference | Bromide, iodide, nitrate, diatrizoate may cause positive interference. | No significant interference observed at tested concentration of interferent: Ascorbic Acid (20 mg/dL), Bilirubin (15 mg/dL), Hemoglobin (300 mg/dL), Total Protein (15 g/dL), Triglycerides (3000 mg/dL) |
Note: The document explicitly states, "The nonclinical and clinical data provided demonstrate that the CARESIDE™ CO2 product is as safe, effective, and performs as well as or better than the legally marketed predicate device." This indicates that the predicate's performance served as the "acceptance criteria" for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "clinical data" or "method comparison" studies.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document refers to "nonclinical and clinical data provided," implying internal studies by CARESIDE, Inc. It does not indicate if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. The document describes an in vitro diagnostic device for quantitative measurement, and ground truth would typically be established by laboratory reference methods rather than expert consensus for individual results.
4. Adjudication Method for the Test Set
- This information is not provided. Given it's a quantitative diagnostic device, adjudication methods like 2+1 or 3+1 are not typically applicable. The comparison is against established laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC study was not done. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. The CARESIDE™ CO2 device is an automated in vitro diagnostic device, not one requiring human interpretation in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, this was a standalone performance study. The CARESIDE™ CO2 cartridge, used with the CARESIDE Analyzer™, is an automated system designed to quantitatively measure total CO2 without human intervention in the measurement process itself, beyond sample loading. The performance characteristics (accuracy, precision, linearity, method comparison, interference) reported are indicative of the device's standalone performance.
7. The Type of Ground Truth Used
- The ground truth for the method comparison and accuracy studies would have been established by comparing the CARESIDE™ CO2 results against a legally marketed predicate device (Vitros CO2 DT Slides) or other established reference methods in a clinical laboratory setting. The "Method comparison" section directly compares the CARESIDE™ results to the Vitros CO2 DT, indicating the Vitros results served as a comparative ground truth.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" sample size. For in vitro diagnostic devices, method validation studies typically encompass "development" or "internal validation" phases which are analogous to a training set, but explicit sample sizes for these are rarely detailed in 510(k) summaries. The reported performance data would generally come from a separate "test set" after method development is complete.
9. How the Ground Truth for the Training Set Was Established
- As a quantitative diagnostic test, the "ground truth" during any developmental or training phase would typically be established against existing, well-established reference methods or predicate devices in a laboratory. The document does not describe the specific process for establishing ground truth during initial development or "training" phases, if any specific "training set" was used for the algorithm. The fundamental principle is that the device is calibrated and its performance evaluated against established, accurate measurements of CO2.
§ 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.