(252 days)
For the quantitative determination of high-density lipprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC720® Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
Not Found
This document is a 510(k) clearance letter for the Carolina Liquid Chemistries HDL Cholesterol Reagent. It is not a study report demonstrating device performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.
However, I can provide what is explicitly stated in the document:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance. It is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. Performance data would typically be found in the 510(k) submission itself, not the clearance letter.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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)
This information is not available in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
This information is not available in the provided document. The device is a "HDL Cholesterol Reagent" and a "Clinical Chemistry Analyzer," which suggests it's an in-vitro diagnostic test for quantitative determination of HDL-C, not an imaging device typically associated with human reader interpretation in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided document. Given the nature of the device (a reagent for an analyzer), its performance would inherently be "standalone" in the sense that the analyzer provides a quantitative result without human "interpretation" in the way an imaging algorithm might. However, this document does not detail performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided document. For a quantitative diagnostic test like this, ground truth would typically be established through a reference method or comparison to other established methods for HDL-C measurement.
8. The sample size for the training set
This information is not available in the provided document.
9. How the ground truth for the training set was established
This information is not available in the provided document.
§ 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.