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ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Cholesterol Reagent assay, cholesterol esters in serum or heparin plasma are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The cholesterol liberated by the esterase, plus any endogenous free cholesterol, are both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance, bichromatically at 505 nm/647 nm, is directly proportional to the cholesterol concentration in the sample.

The HDL-C Assay utilizes two reagents, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.

In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.

In the ACE Triglycerides Reagent assay, triglycerides in serum or heparin plasma are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and study details for the Alfa Wassermann ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, and ACE Triglycerides Reagent, based on the provided 510(k) summary:

The studies presented are "matrix comparison data" studies, aiming to demonstrate substantial equivalence between using serum and lithium heparin plasma samples with the new ACE reagents on the ACE and ACE Alera Clinical Chemistry Systems. The performance is assessed by comparing quantitative measurements from paired serum/plasma samples.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating strong correlation and agreement between serum and plasma measurements, specifically looking for regression equations close to y=x (slope near 1, intercept near 0) and high correlation coefficients. The provided confidence intervals for slope and intercept also serve as an implicit measure of acceptance.

2. Sample Size Used for the Test Set and Data Provenance

• ACE Cholesterol Reagent (ACE Clinical Chemistry System): 102 paired samples (serum and lithium heparin plasma). 5 samples spiked.
• ACE Cholesterol Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma). 6 samples spiked.
• ACE HDL-C Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma).
• ACE HDL-C Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma).
• ACE LDL-C Reagent (ACE Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
• ACE LDL-C Reagent (ACE Alera Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
• ACE Triglycerides Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
• ACE Triglycerides Reagent (ACE Alera Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.

Data Provenance: The data provenance is described as "paired samples drawn from the same patients." There is no explicit mention of the country of origin of the data, but the context of an FDA 510(k) submission for commercialization in the USA suggests it would likely be from a US-based or internationally recognized clinical setting. The studies are prospective in nature, as they involve drawing paired samples for direct comparison. Spiking of some samples was done to extend the measurement range.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not involve "experts" establishing a ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth for each measurement type (Cholesterol, HDL-C, LDL-C, Triglycerides) is the quantitative value obtained from the serum sample, which serves as the established reference matrix. The performance of the devices is then compared against this reference when using plasma samples. Therefore, no external experts were used for this purpose; the "ground truth" is the instrumental measurement itself.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative laboratory test performance study, not an expert-driven adjudication of medical findings. The comparison is statistical (Deming regression) between instrument measurements from two different sample matrices (serum vs. plasma).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a study evaluating the performance of in-vitro diagnostic reagents and systems, not an AI-assisted diagnostic device involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This study evaluates the standalone performance of the reagent and instrument system when used with different biological matrices (serum vs. plasma). There is no "human-in-the-loop" component in the interpretation of the numerical results beyond standard laboratory quality control and reporting procedures. The results provided are direct numerical outputs from the analytical instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used in these studies is the quantitative measurement of the analytes (Cholesterol, HDL-C, LDL-C, Triglycerides) obtained from serum samples using the same ACE and ACE Alera Clinical Chemistry Systems. Serum is generally considered the standard matrix for these assays. The purpose of the study is to demonstrate that lithium heparin plasma samples yield comparable results to serum samples.

8. The sample size for the training set

Not applicable. This is a performance validation study for a medical device (reagents and instrument system), not a machine learning model that requires a distinct training set. The "training" in this context would refer to the development and optimization of the reagents and assay protocols, which typically occurs during the R&D phase and doesn't involve a formal "training set" as understood in AI/ML.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of machine learning. The reagents are developed to specifically measure the target analytes based on well-established biochemical principles (enzymatic reactions). The "ground truth" for the development of such assays would involve chemical standards, certified reference materials, and comparison to established reference methods, but this is part of the assay development, not a "training set" for the reported performance studies.

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