(109 days)
The Macra® Lp(a) Enzyme Linked Immunosorbant Assay (ELISA) kit, is an in vitro diagnostic device for the quantitative measurement of Lp(a), in human serum or plasma, for the assessment of risk for coronary heart disease (CHD) in specific populations, along with other risk factors.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Macra® Lp(a) Enzyme Immunoassay Kit." This document does not contain the acceptance criteria or a study detailing device performance. It is a regulatory approval letter stating that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information from this document. The information typically found in such a study would include:
- A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, linearity, detection limits, etc., and compare them against predetermined thresholds.
- Sample size used for the test set and the data provenance: Information on the number of samples used for validation and where these samples originated (e.g., patient cohorts, geographical locations, retrospective or prospective collection).
- Number of experts and their qualifications: Not applicable for an immunoassay. This is relevant for devices involving human interpretation of results (e.g., imaging devices).
- Adjudication method: Not applicable for an immunoassay. This is relevant for devices involving human interpretation of results.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable for an immunoassay, as the device provides quantitative measurements. This is relevant for devices that assist human readers in making diagnoses or interpretations (e.g., CAD systems for radiology).
- Standalone performance: This document implicitly refers to the standalone performance of the assay itself, but provides no data. For an immunoassay, "standalone" means the performance of the kit in measuring the analyte.
- Type of ground truth used: For an immunoassay, the ground truth for performance evaluation usually involves reference methods (e.g., mass spectrometry, established gold-standard assays) for quantitative comparisons, or clinical outcomes for risk assessment validation. This document does not specify.
- Sample size for the training set: Not applicable for a traditional immunoassay, which does not typically involve machine learning training in the same way an AI-powered device would. Its "training" is more akin to assay optimization and calibration.
- How the ground truth for the training set was established: Not applicable for a traditional immunoassay in the context of machine learning.
The document states the device's "Indications for Use": The Macra® Lp(a) Enzyme Linked Immunosorbant Assay (ELISA) kit, is an in vitro diagnostic device for the quantitative measurement of Lp(a), in human serum or plasma, for the assessment of risk for coronary heart disease (CHD) in specific populations, along with other risk factors. This indicates the intended purpose, but not the performance metrics or study details.
To obtain the requested information, one would typically need to consult the full 510(k) submission, including the performance studies submitted to the FDA, or related peer-reviewed publications.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).