(43 days)
The CARESIDE™ HDL-Cholesterol cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CARESIDE™ Analyzer to quantitatively measure HDL-cholesterol concentration in pre-treated serum or plasma. This product is indicated for use in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism.
CARESIDE™ HDL-Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure HDL-cholesterol concentration in pre-treated serum or plasma specimens. The CARESIDE™ HDL-Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of pre-treated serum or plasma to a dry film to initiate the measurement of HDL-cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure HDL-cholesterol concentration.
Here's a breakdown of the acceptance criteria and the study information for the CARESIDE™ HDL-Cholesterol device, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (Predicate) | Reported Device Performance (CARESIDE™ HDL-Cholesterol) |
|---|---|---|
| Detection Limit | 1 mg/dL | 10 mg/dL |
| Reportable Range | 1 to 110 mg/dL | 10 to 110 mg/dL |
| Accuracy | Not provided | Mean recovery 109% |
| Precision | Total CV, 41 mg/dL, 3.2% | Total CV, 33 mg/dL, 6.5% |
| Method Comparison (Correlation to Predicate) | N/A (Predicate vs. Unknown) | CARESIDE™ = 0.97 (Vitros HDLC DT) - 1.5 mg/dL, r = 0.97 |
| Linearity | Not provided | Linearity by mixing and by dilution yielded slope and correlation coefficient within acceptable limits. |
| Interference | Ascorbic Acid interferes (non-interfering concentration undefined) | No significant interference observed at tested concentration of interferent: Ascorbic Acid, 1 mg/dL; Bilirubin, 10 mg/dL; Hemoglobin, 250 mg/dL; Protein 5 - 9 g/dL; Triglycerides 1500 mg/dL |
Note: The acceptance criteria are inferred from the reported performance of the predicate device (Vitros HDLC DT Slides) where specific criteria for the new device are not explicitly stated, or from the new device's demonstrated performance exceeding or meeting expectations related to the predicate.
Study Information
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the test set.
- The document does not explicitly state the country of origin of the data.
- The document does not explicitly state if the data was retrospective or prospective.
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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 study focuses on comparing the device's measurements to a predicate device, not on expert-adjudicated ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or provided. The study is a quantitative measurement comparison, not an analysis requiring adjudication of interpretations.
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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:
- No, a MRMC comparative effectiveness study was not done. This is a study comparing an in vitro diagnostic device's quantitative measurements to a predicate device, not an AI-assisted human reader study.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the algorithm's performance in measuring HDL-cholesterol concentration in pre-treated serum or plasma specimens, without human-in-the-loop performance influencing the measurement itself. The "CARESIDE™ HDL-Cholesterol" device, in conjunction with the CARESIDE™ Analyzer, performs the measurement automatically.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for the comparative performance study was the measurements obtained from the predicate device, Vitros HDLC DT Slides. Additionally, some tests (like linearity) might have been assessed against theoretical expectations or known concentrations of reference materials. The "Reference Method" for the CARESIDE™ is stated as "Abell Kendall," implying this might be a recognized standard against which the predicate or even the new device could be ultimately traceable, though the direct comparison in the table is against the Vitros HDLC DT.
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The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. This type of premarket notification for an IVD kit typically presents validation data, not a machine learning model's training details.
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How the ground truth for the training set was established:
- As no training set is mentioned (see point 8), the method for establishing its ground truth is also not applicable or provided.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.