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510(k) Data Aggregation
(212 days)
For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
This in vitro diagnostic device is intended for Rx Only.
The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.
The provided text describes the acceptance criteria and performance of the LIQUID CO2-2 (LCO2-2) device, which is an in vitro diagnostic for quantitative determination of Carbon Dioxide in serum and plasma.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | (Not explicitly stated as a single numerical criterion, but evaluated consistent with CLSI EP5-A2 guidelines) | QC Level 3: SD 0.79, CV 4.5%QC Level 2: SD 0.63, CV 5.5%SP Level 1: SD 0.75, CV 6.7%SP Level 2: SD 0.93, CV 5.0%SP Level 3: SD 1.33, CV 3.8% |
| Linearity/Reportable Range | Deviation from linearity < 5% | Reportable Range: 10 to 40 mEq/LLinear Regression: Y = 0.99 + 0.75Correlation Coefficient (r): 0.999 |
| Open Vial Stability | Percentage deviation of stable to fresh should be ≤5% | Supports a reconstituted claim of 28 days when stored at +2°C to +8°C. |
| Real Time (Shelf Life) Stability | All controls should be within range | Supports a 2-year shelf life when stored at +2 to +8°C. |
| Limit of Blank (LoB) | (Not explicitly stated as a numerical criterion, but determined per CLSI EP17-A2) | 0.97 mEq/L |
| Limit of Detection (LoD) | (Not explicitly stated as a numerical criterion, but determined per CLSI EP17-A2) | 1.98 mEq/L |
| Limit of Quantitation (LoQ) | (Not explicitly stated as a numerical criterion, but determined by precision) | 4.5 mEq/L (as determined by the lowest concentration at which precision is still met) |
| Analytical Specificity (Interference) | Recovery within ±10% of the initial value of Carbon Dioxide concentration of 20 mEq/L and 35 mEq/L | Hemoglobin: No significant interference up to 1000mg/dLTotal Bilirubin: No significant interference up to 60mg/dLConjugate Bilirubin: No significant interference up to 30mg/dLTriglycerides: No significant interference up to 2000mg/dLIntralipid®: No significant interference up to 2000mg/dLAscorbic Acid: No significant interference up to 6.0mg/dL |
| Method Comparison (vs. Predicate) | (Not explicitly stated as a single numerical criterion, but linear regression and correlation coefficient are provided for comparison) | Linear Regression: Y = 0.97x - 0.11Correlation Coefficient (r): 0.994 |
| Matrix Comparison (Serum vs. Lithium Heparin Plasma) | (Not explicitly stated as a single numerical criterion, but linear regression and correlation coefficient are provided for comparison) | Linear Regression: Y = 0.97x + 0.94Correlation Coefficient (r): 0.984 |
| Reference Interval Verification (Expected Values) | All values reported in the range for Healthy Individuals | All values from 30 normal donors were within the quoted ranges for Carbon Dioxide (20 – 31 mEq/L). |
2. Sample size used for the test set and the data provenance:
- Precision: 80 samples for each level (QC Level 3, QC Level 2, SP Level 1, SP Level 2, SP Level 3). The samples included serum-based control material and unaltered human serum samples (spiked or diluted).
- Linearity: 11 levels, tested in replicates of five.
- Method Comparison: 97 serum patient samples.
- Matrix Comparison: 50 matched patient sample pairs (serum and lithium heparin plasma).
- Reference Interval Verification: Human serum from 30 normal donors.
Data provenance is not explicitly stated in terms of country of origin but is implied to be clinical laboratory testing. The studies appear to be prospective, specifically designed for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
The document does not mention the use of experts to establish ground truth. These are in vitro diagnostic tests, where the "ground truth" for method comparison and similar studies is typically established by the results from a legally marketed (predicate) device or established analytical methods. For reference intervals, the ground truth is based on established clinical ranges and validated literature.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This document describes analytical performance studies for an in vitro diagnostic device, not studies involving human readers or 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 an in vitro diagnostic device study, not an AI-assisted human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, all presented performance data (Precision, Linearity, Stability, Detection Limits, Interference, Method Comparison, Matrix Comparison) are for the device (LCO2-2) operating in a standalone, automated manner on an RX Daytona plus system, without human intervention in the analytical measurement workflow.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Method Comparison: The predicate device (Siemens ADVIA Chemistry Carbon Dioxide Liquid (CO2 L) on an ADVIA 1650 system) serves as the reference or "ground truth" for comparison.
- Traceability (Calibrator): The calibrator is traceable to Sodium Carbonate NIST reference material 351.
- Reference Interval Verification: Referenced from literature (Tietz NW. Clinical Guide to Laboratory Tests. 3rd ed.) and verified against human serum from normal donors.
8. The sample size for the training set:
Not applicable. This document details the analytical validation of an in vitro diagnostic reagent, not the development or training of a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. The "ground truth" for the calibrators and predicate device is established through their respective validation processes and traceability to reference materials/methods.
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