(246 days)
The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
For use in clinical laboratories and point of care laboratory settings.
For prescription use only.
Afinion™ Lipid Panel is a fully automated assay for quantitative determination of Chol. HDL and Trig in serum. LDL, non- HDL and Chol/HDL are calculated by the Afinion™ AS100 Analyzer.
The Afinion™ Lipid Panel Test Cartridge contains all reagents necessary for determination of Chol, HDL and Trig in serum. The sampling device integrated in the test cartridge is filled with sample material. The test cartridge is then placed in the Afinion™ AS100 Analyzer. The analyzer inspects the sampling device, and the sample is then diluted.
Total Cholesterol (Chol) is measured by an enzymatic colorimetric method.
Triglycerides (Trig) are measured by an enzymatic colorimetric method.
HDL cholesterol is measured by an enzymatic colorimetric method with direct determination of HDL by initial antibody blocking of apolipoprotein B (apo-B).
LDL cholesterol is calculated by use of the Friedwald formula: LDL (mg/dL) = Chol - HDL - Trig/5.
non-HDL cholesterol is calculated as total cholesterol minus HDL: non-HDL = Chol - HDL.
Chol/HDL ratio is calculated as Total Cholesterol/ HDL Cholesterol.
Acceptance Criteria and Device Performance for Afinion™ Lipid Panel
This document outlines the acceptance criteria and the study that demonstrates the Afinion™ Lipid Panel's performance, as derived from the provided 510(k) summary (K132031).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria values for bias, precision (repeatability and within-device), or linearity. Instead, it presents the results of these studies and implies that these results were considered acceptable for demonstrating substantial equivalence to predicate devices. The reported device performance based on acceptable outcomes from comparison studies is presented below.
Interference: No significant interference (
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.