(29 days)
For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
CareSide™ Total Protein cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure total protein concentration in whole blood, plasma or serum specimens. The CareSide™ Total Protein cartridge, a single use disposable in vitro diagnostic test carridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total protein concentration. The film cartridge (patent pending) contains all reagents necessary to measure total protein concentration. When used in conjunction with the CareSide™ Albumin cartidge on the CareSide™ Analyzer, the analyzer calculates globulin (as the difference between the total protein and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
Here's a summary of the acceptance criteria and study information for the CareSide™ Total Protein device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria / Predicate Performance | CareSide™ Total Protein Performance |
|---|---|---|
| Detection Limit | 2 g/dL | 2 g/dL |
| Reportable Range | 2.0 to 11 g/dL | 2.0 to 11 g/dL |
| Accuracy | Not provided for predicate | Mean recovery 105% |
| Precision | Total CV, 4.5 g/dL: 2.5% (Vitros TP DT) | Total CV, 6.0 g/dL: 7.2% |
| Method Comparison | Not provided for predicate | CareSide™ = 0.9 (Vitros Total Protein DT) + 0.56, r=0.93 |
| Linearity | Not provided for predicate | Mean deviation approx 1%, r² ≥0.99 |
| Interference | Not provided for predicate | No significant interference observed at tested concentrations of Ascorbic Acid (20 mg/dL), Bilirubin (20 mg/dL), Hemoglobin (250 mg/dL), Triglycerides (1500 mg/dL). |
| Specimen Types & Anticoagulants | No clinically significant difference between serum and heparin plasma. Whole blood unsuitable (Vitros TP DT). | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. |
| Expected Values (Reference Range) | 6.3 to 8.2 g/dL (combined male and female, Central 95% interval) (Vitros TP DT) | 6.3 to 8.4 g/dL (combined male and female, Central 95% interval) |
Note on Acceptance Criteria: The document primarily uses the predicate device's performance characteristics or a "not provided" statement as a benchmark. For some metrics like Accuracy, Linearity, and Interference, the CareSide™ device reports its own performance without a direct comparison to a specific quantitative acceptance criterion from the predicate, implying these met general expectations for such a device. The conclusion states the device "performs as well as or better than the legally marketed predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Specific sample sizes for each performance characteristic (accuracy, precision, method comparison, linearity, interference studies) are not explicitly provided in the given text.
- Data Provenance: The studies appear to be clinical performance evaluations conducted by Exigent Diagnostics, Inc. The location and whether they were retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The data presented is quantitative analytical performance, presumably compared against established laboratory methods or reference values, not expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are for analytical performance, not for subjective interpretation or agreement between multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic test for measuring total protein concentration, not a device requiring human interpretation of results in the way an imaging diagnostic device might.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The reported performance characteristics (accuracy, precision, linearity, etc.) represent the performance of the CareSide™ Total Protein cartridge and CareSide™ Analyzer system as a standalone diagnostic device, without human interpretive input beyond following the operational instructions. The device directly measures and reports a quantitative result.
7. The Type of Ground Truth Used
The ground truth for the device's performance (e.g., accuracy, method comparison, linearity) would have been established using:
- Reference Methods: The "Reference Method" is stated as Biuret, which is a widely accepted laboratory method for total protein measurement.
- Predicate Device Data: For comparison, the predicate device (Vitros Total Protein DT Slides) served as a benchmark.
- Standard Calibrators/Controls: For linearity and precision studies, calibrated materials with known concentrations would have been used.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a chemical assay system with a fixed reaction sequence and measurement principle, not a machine learning or AI-based device that would typically involve a "training set" in the conventional sense of AI model development. The system uses a "lot-specific standard curve" for calculation, which implies calibration data for each lot, but this is distinct from training a machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The device operates based on established chemical reactions and calibration curves rather than an AI training process.
§ 862.1635 Total protein test system.
(a)
Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.