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The Sigma Diagnostics EZ™ LDL- cholesterol test system is a device intended to measure LDL-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.

The Sigma Diagnostics EZ LDL procedure is based on an enzymatic selective protection (ESP) methodology. When a sample is mixed with EZ LDL Reagent 1, the protecting reagent binds to LDL and protects LDL from enzyme reactions. Cholesterol esterase (CHE) and cholesterol oxidase (CO) react with non-LDL lipoproteins (chylomicrons(CM), very low-density lipoprotein (VLDL) and HDL). Hydrogen peroxide produced by the enzyme reactions with non-LDL cholesterol is decomposed by catalase in EZ Reagent 1. When EZ LDL Reagent 2 is added, the protecting reagent is removed from LDL and catalase is inactivated by sodium azide (NaNJ). In this second process, CHE and CO react only with LDL-C. Hydrogen peroxide produced by the enzyme reactions with LDL-C yields a color complex upon oxidase condensation with N-(2hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HDAOS) and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 nm, the LDL-C concentration in the sample can be calculated when compared with the absorbance of the LDL-C calibrator.

This document is a 510(k) summary for the Sigma Diagnostics EZ LDL-C™ Test System, a device intended to measure LDL-cholesterol in plasma and serum. This submission does not contain the requested information regarding acceptance criteria, study details, and performance measures associated with device validation.

The document primarily focuses on:

• Description of the device: It explains the enzymatic selective protection (ESP) methodology used by the EZ LDL-C™ Test System.
• Comparison to a predicate device: It states that the device is substantially equivalent to, and the same product as, the Wako Chemical USA, Inc. Direct LDL-C test system (K982271).
• Intended Use/Indications for Use: To measure LDL-cholesterol in plasma and serum for diagnosing and treating disorders involving excess cholesterol and lipid/lipoprotein metabolism.
• Regulatory communication: The letter from the FDA acknowledging the 510(k) notification and deeming the device substantially equivalent.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text.

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