(51 days)
For in vitro diagnostic use with Exigent Diagnostics' CARESIDE™ Analyzer to measure total cholesterol from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism
CARESIDE™ Total Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure total cholesterol concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Total Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure total concentration of cholesterol.
The Exigent Diagnostics CARESIDE™ Total Cholesterol device is a quantitative in vitro diagnostic system for measuring total cholesterol in anti-coagulated whole blood, plasma, or serum specimens when used with the CARESIDE™ Analyzer. The device's performance was evaluated by comparing it to the legally marketed predicate device, Johnson and Johnson’s Vitros CHOL Slides for the Vitros DT 60 II. The study focused on accuracy, precision, and method comparison.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly defined in terms of specific performance targets (e.g., "accuracy must be >95%"). Instead, the document demonstrates substantial equivalence by presenting comparative performance characteristics against a predicate device. The implicit acceptance criterion is that the CARESIDE™ device performs as well as or better than the predicate device for key metrics.
| Performance Characteristic | Acceptance Criteria (Implicit: As good as or better than predicate) | CARESIDE™ Total Cholesterol Performance | Predicate Device (Vitros CHOL DT Slides) Performance |
|---|---|---|---|
| Detection Limit | 50 mg/dL | 50 mg/dL | 50 mg/dL |
| Reportable Range | At least 50 to 325 mg/dL | 50 to 450 mg/dL | 50 to 325 mg/dL |
| Accuracy | Not explicitly defined, but assumed to be acceptable | Mean recovery 106% | Not provided |
| Precision | Comparable to predicate (e.g., CV%) | Total CV, 203 mg/dL, 5.2% | Total CV, 202 mg/dL, 3.4% |
| Method Comparison | Strong correlation with predicate | CARESIDE™ = 1.04 (Vitros CHOL DT) + 23 mg/dL, r = 0.94 | Not provided |
| Linearity | Within acceptable limits | Linearity by mixing and by dilution yielded slope and correlation coefficient within acceptable limits | Not provided |
| Interference | No significant interference at specified concentrations | No significant interference observed at: | |
| Ascorbic acid 1 mg/dL | |||
| Bilirubin 10 mg/dL | |||
| Hemoglobin 250 mg/dL | |||
| Protein 5 to 9 g/dL | |||
| Triglyceride 600 mg/dL | Very high protein > 10 mg/dL |
The study concludes that the nonclinical and clinical data provided demonstrate that the CARESIDE™ Total Cholesterol product is as safe, effective, and performs as well as or better than the legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the provided sections. Details regarding the number of patient samples (e.g., for accuracy, precision, or method comparison studies) are not given.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the context of a 510(k) summary for a diagnostic device seeking U.S. market clearance, it is highly probable that the studies were conducted in the U.S. or followed U.S. regulatory guidelines for clinical data. The studies would typically be prospective for clinical performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The Exigent Diagnostics CARESIDE™ Total Cholesterol is an in vitro diagnostic (IVD) device for quantitative measurement of a biochemical analyte (total cholesterol). The "ground truth" for measuring cholesterol concentration is established by a reference method (Abell Kendall in this case) and validated laboratory procedures, not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is based on quantitative chemical measurements against a reference method (Abell Kendall), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The CARESIDE™ device is an automated in vitro diagnostic test for measuring a chemical concentration; therefore, MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance presented for the CARESIDE™ device is standalone performance. The device automatically measures cholesterol concentration by processing the sample and uses its internal algorithm (based on reflectance measurements and a lot-specific standard curve) to calculate the total cholesterol concentration. The performance metrics (accuracy, precision, linearity, method comparison, interference) represent the device's capability to provide measurements independently of human interpretation of the final result, beyond the initial sample application and instrument operation.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation of the CARESIDE™ Total Cholesterol device typically relies on established reference methods and laboratory standards. Specifically, the document states:
- Reference Method: Abell Kendall. This method is a widely accepted and rigorous chemical method for determining cholesterol concentration and serves as the gold standard for accuracy comparisons.
- Comparative Method: Vitros CHOL DT Slides (predicate device), which itself is compared to and validated against established reference methods.
Therefore, the ground truth is primarily based on chemical reference methods/laboratory standards.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. For an IVD device, the "training set" would typically refer to data used during the development and calibration of the device's algorithms and standard curves. This information is generally part of the internal development process and not always detailed in the 510(k) summary unless specific machine learning components require it for regulatory review, which is less common for enzymatic assays like this.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, based on typical IVD development, the ground truth for establishing calibration curves and optimizing the enzymatic reactions would involve:
- Known concentration standards: Using commercially available or internally prepared solutions with precisely known cholesterol concentrations.
- Reference laboratory measurements: Analyzing samples using established reference methods (like Abell Kendall or other highly accurate laboratory methods) to determine their true cholesterol levels, which are then used to develop and validate the device's calibration.
This process ensures that the device's measurements are accurate across its reportable range.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.