(72 days)
For use in clinical laboratories and physicians' office laboratories for quantitative determination of low density lipoprotein (LDL) cholesterol in human serum as a risk factor in coronary artery disease.
Not Found
This is an FDA Premarket Notification (510(k)) for the RDI Direct LDL Reagent (also referred to as RDI Direct LDL Cholesterol Test). This document confirms substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or specific study results that prove the device meets such criteria because 510(k) submissions typically rely on comparison to existing predicate devices rather than novel performance studies outlining acceptance criteria for a new type of device.
Therefore, most of the requested information cannot be found in the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The document is an FDA letter granting substantial equivalence, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not describe a clinical study.
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)
- Cannot be answered from the provided text. The document does not describe a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. The document does not describe a clinical study.
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
- Cannot be answered from the provided text. This device is a reagent for measuring LDL cholesterol, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the provided text. This device is a reagent, not an algorithm. Performance of the reagent itself would typically be evaluated without human-in-the-loop unless it's an interpretation step, but the document doesn't provide such details.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. The document does not describe a clinical study. For a diagnostic reagent, ground truth would typically be established by a reference method for the analyte being measured.
8. The sample size for the training set
- Cannot be answered from the provided text. The document does not describe a clinical study or an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. The document does not describe a clinical study or an algorithm requiring a training set.
§ 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.