(29 days)
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure albumin from whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of numerous diseases involving mainly the liver or kidneys.
CareSide™ Albumin cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure albumin concentration in whole blood, plasma or serum specimens. The Careshie Albumin carridge, a single use disposable in virro diagnostic test carridge, aids in speciment separation and delivers a measured volume of plasma or sorum to a dry film to initiate the moasuroment of albumin concentration. The film cartidge (patent pending) contains all reagons and necessary to measure albumin concentration. When used in conjunction with the CareSide™ Total Protein carridge on the CareSidorM Analyzer calculates globulin (as the I vial Prolent Caral go on the and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
This document describes the validation of the CareSide™ Albumin device for measuring albumin concentration in whole blood, plasma, or serum specimens.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents "Comparative Performance Characteristics" which serve as the acceptance criteria and the device's reported performance against them.
| Acceptance Criteria / Performance Characteristic | CareSide™ Albumin Reported Performance | Predicate Device (Vitros Albumin DT Slides) Reported Performance |
|---|---|---|
| Detection limit | 1 g/dL | 1 g/dL |
| Reportable range | 1.0 to 6.0 g/dL | 1.0 to 6.0 g/dL |
| Accuracy | Mean recovery 107% | Not provided |
| Precision | Total CV, 4.3 g/dL 5.3% | Total CV, 4.2 g/dL 2.1% |
| Method comparison (vs. Vitros Albumin DT) | CareSide™ = 0.95 (Vitros Albumin DT) + 0.14, r=0.96 | Not applicable (this is the predicate) |
| Linearity | Mean deviation approx 5%. r > 0.99 | Not provided |
| Interference | No significant interference observed at tested concentration of interferent: Ascorbic Acid, 20 mg/dL; Bilirubin, 20 mg/dL; Hemoglobin, 250 mg/dL; Triglycerides 3000 mg/dL | Not provided |
| Specimen Types & Anticoagulants | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum and heparin plasma. Whole blood is unsuitable. |
| Expected Values | 3.6 to 4.5 g/dL (combined male and female); Central 95% interval | 3.5 to 5.0 g/dL referenced from literature |
Conclusion from section VII.D: The nonclinical and clinical data provided demonstrate that the CareSide™ Albumin 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 states "The nonclinical and clinical data provided" but does not specify the sample size for the test set used in the comparative performance characteristics.
Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications
There is no information provided in the document about the number or qualifications of experts used to establish ground truth for the test set. Given this is an in vitro diagnostic device measuring a quantitative analyte, the "ground truth" would likely be established by a reference laboratory method or reference instrument, not by expert consensus on interpretations.
4. Adjudication method for the test set
No information is provided regarding an adjudication method for the test set. For a quantitative measurement device, an "adjudication method" in the sense of resolving conflicting interpretations by multiple readers (e.g., 2+1, 3+1) is not applicable. Accuracy is typically determined by comparing the device's measurements to a reference method or known concentrations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
No MRMC comparative effectiveness study was done or mentioned. This device is an in vitro diagnostic test for measuring an analyte, not an imaging device that would typically involve human readers interpreting cases with and without AI assistance. Therefore, human readers' improvement with AI assistance is not applicable here.
6. If a standalone (algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (detection limit, reportable range, accuracy, precision, linearity, interference) represent the standalone performance of the CareSide™ Albumin device (algorithm/system only). While a user initiates the test, the measurement and calculation of albumin concentration are automated by the device without human interpretation of the results through a human-in-the-loop process beyond reading the displayed concentration.
7. The type of ground truth used
The ground truth for the comparative performance was likely established by:
- Reference Method: For accuracy, precision, and linearity, the device's measurements would be compared against a recognized reference method (e.g., "Bromocresol green (wet)" is mentioned as a reference method in the technical characteristics table) or a highly accurate laboratory instrument.
- Known Concentrations: For assessing detection limit, reportable range, and linearity, samples with precisely known concentrations of albumin would be used.
- Predicate Device: The "Method comparison" section explicitly compares the CareSide™ Albumin to the "Vitros Albumin DT" slides, indicating the predicate device served as a reference for comparison in this aspect.
8. The sample size for the training set
The document does not specify the sample size for the training set.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for any potential training set was established. For an in vitro diagnostic device like this, method development and calibration would typically involve using samples with known albumin concentrations, often verified by a reference method.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.