(23 days)
This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.
Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.
An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent, which is added as part of the second reagent, together with cholesterol enzymes. HDL particles are not stabilized by the polymers and polyanions and become solubilized by the detergent. As a result, only the HDL cholesterol is subject to measurement.
The ACE™ HDL-C Reagent is intended for the quantitative determination of HDL cholesterol in human serum. The study provided focuses on establishing substantial equivalence to a predicate device (N-geneous™ HDL Cholesterol Reagent) and to a CDC reference method, rather than specifically defining explicit acceptance criteria in a regulatory sense for a single-arm study. The performance assessment compares key metrics to both the predicate device and the CDC reference method.
Here's the breakdown of the information requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents performance summaries for comparison against a predicate device and a reference method, with the implicit acceptance being that the proposed device performs comparably. The document states that "Based on these data, the Schiapparelli Biosystems ACE™ HDL-C reagent is substantially equivalent to the Centers for Disease Control Reference Method and the predicate device, the Genzyme N-geneous HDL Cholesterol Reagent."
| Parameter | Implied "Acceptance Criteria" (from Predicate/CDC) | Proposed Device Performance (ACE™ HDL-C Reagent) |
|---|---|---|
| Assay Range | Predicate: 2 mg/dL to 200 mg/dL | 2 mg/dL to 100 mg/dL |
| Precision | ||
| Within Run (% CV) | Predicate: |
§ 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.