(130 days)
HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.
HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.
HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
This direct HDL Cholesterol method is a homogeneous assay without the need for any offline pretreatment or centrifugation steps. The method depends on a unique detergent which solubilizes only the HDL lipoprotein particles and releases HDL cholesterol to react with cholesterol esterase and cholesterol oxidase in the presence of chromogens, to produce a color product. The same detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicrons lipoproteins by adsorbing to their surfaces. A polyanion contained in the reagent enhances the selectivity for HDL cholesterol assay by complexing LDL, VLDL, and chylomicrons lipoproteins.
HDLX reagent is used to measure the cholesterol concentration by a timed-endpoint method. The SYNCHRON® System(s) automatically proportions the appropriate HDL cholesterol sample and reagent volumes into a cuvette. The ratio used is one part sample to 93 parts reagent. The System monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration.
{
"1_table_of_acceptance_criteria_and_reported_device_performance": {
"Method Comparison Study (vs. Olympus HDLX Assay)": {
"Platform": [
"UniCel DxC 800",
"LX20"
],
"Acceptance Criteria (implicit based on R value)": [
"High correlation (R near 1)"
],
"Reported Device Performance": [
"R = 0.991",
"R = 0.984"
]
},
"Precision Study (Within-Run Imprecision)": {
"Platform and Sample": [
"UniCel DxC 800 - SYN 1",
"UniCel DxC 800 - SYN 2",
"UniCel DxC 800 - SYN 3",
"UniCel DxC 800 - Vigil Lipid 1",
"UniCel DxC 800 - Vigil Lipid 2",
"UniCel DxC 800 - Vigil Lipid 4",
"LX20 - SYN 1",
"LX20 - SYN 2",
"LX20 - SYN 3",
"LX20 - Vigil Lipid 1",
"LX20 - Vigil Lipid 2",
"LX20 - Vigil Lipid 4"
],
"Acceptance Criteria (implicit based on %C.V.)": [
"Low imprecision (low %C.V.)"
],
"Reported Device Performance (%C.V.)": [
"1.66",
"0.85",
"0.82",
"1.83",
"1.13",
"0.85",
"1.05",
"0.77",
"0.87",
"1.64",
"1.33",
"1.39"
]
}
},
"2_sample_size_and_data_provenance": {
"Method Comparison Study": {
"Sample Size (Test Set)": "100 samples for each platform (UniCel DxC 800 and LX20)",
"Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
},
"Precision Study (Within-Run Imprecision)": {
"Sample Size (Test Set)": "20 replicates for each of 6 samples on each platform (UniCel DxC 800 and LX20), totaling 240 measurements (20 * 6 * 2).",
"Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
}
},
"3_number_of_experts_and_qualifications_for_ground_truth": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring expert ground truth for classification.",
"4_adjudication_method": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring adjudication.",
"5_mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a diagnostic reagent, not an AI-assisted interpretation device for human readers.",
"6_standalone_performance_done": "Yes, standalone performance was done for both method comparison and precision studies. The studies compare the device's performance against a predicate device and evaluate its consistency.",
"7_type_of_ground_truth_used": {
"Method Comparison Study": "The 'ground truth' was established by the predicate method, the Olympus HDLX Assay ([K040692](https://510k.innolitics.com/search/K040692)). The study aims to demonstrate substantial equivalence to this legally marketed device.",
"Precision Study": "The 'ground truth' is the quantitative measurement itself, assessed for its consistency and reliability (imprecision). There isn't an external 'ground truth' in the same sense as a diagnostic gold standard; rather, it measures the inherent reproducibility of the device."
},
"8_sample_size_for_training_set": "Not applicable/Not specified. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense.",
"9_how_ground_truth_for_training_set_was_established": "Not applicable. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense."
}
§ 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.