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The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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.

The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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.

The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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.

The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. 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.

The ACE Cholesterol Reagent is composed of a single reagent bottle. The reagent contains 4-aminoantipyrine, p-hydroxybenzoic acid, cholesterol oxidase, cholesterol esterase and peroxidase.

The HDL-C Reagent assay utilizes two reagent bottles, 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 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.

The provided text describes a 510(k) submission for the ACE Axcel Clinical Chemistry System and its associated reagents for Cholesterol, HDL-C, LDL-C, and Triglycerides. The submission focuses on demonstrating substantial equivalence to a predicate device (K113262) by showing that the new device has "Same" intended use, instrument platform, basic principle, and reagent composition, with the only difference being the expanded sample type (serum and lithium heparin plasma for the candidate device vs. serum only for the predicate device).

The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study, which aim to show that the expanded sample type (lithium heparin plasma) does not negatively impact the accuracy and precision of the measurements compared to serum. The study largely relies on analytical performance data rather than clinical outcomes or expert consensus on interpretations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document; instead, the study intends to demonstrate comparable performance to the predicate device and acceptable analytical characteristics. The reported device performance for precision and matrix comparison is provided below, which implicitly became the "accepted" performance for the expanded sample type.

2. Sample size used for the test set and the data provenance

• Precision/Reproducibility Study (Test Set):
  • For each analyte (Cholesterol, HDL-C, LDL-C, Triglycerides), for both serum and plasma, 3 levels of samples were used.
  • Each level was tested with 2 replicates, twice a day, on 5 separate days, yielding a total of 20 replicates per level (3 levels * 2 sample types * 20 replicates/level = 120 total measurements per analyte category, e.g., Cholesterol on Serum).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a laboratory setting, likely in the US (given the FDA submission). It is a prospective analytical study designed to evaluate device performance under controlled conditions.
• Matrix Comparison Study (Test Set):
  • Cholesterol: 54 paired serum and lithium heparin plasma specimens.
  • HDL-C: 53 paired serum and lithium heparin plasma specimens.
  • LDL-C: 54 paired serum and lithium heparin plasma specimens.
  • Triglycerides: 55 paired serum and lithium heparin plasma specimens.
  • These specimens covered the assay's dynamic range.
  • Data Provenance: Not explicitly stated, but likely from a clinical laboratory setting, potentially within the US. The samples are retrospective specimens collected for analytical comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of submission for in vitro diagnostic reagents does not typically involve human experts establishing "ground truth" through interpretation. The "ground truth" for the test set is established by comparative measurements against a reference method or the predicate device, and by the inherent chemical/physical properties of the samples used in reproducibility studies. No information about experts or their qualifications is provided or relevant in this context.

4. Adjudication method for the test set

Not applicable. This is an analytical performance study for laboratory reagents, not a clinical study involving human interpretation that would require an adjudication method.

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 not an AI/imaging device, nor does it involve human readers or case interpretations. It is an in vitro diagnostic reagent.

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

This is an analytical device, and its performance is inherently standalone in terms of generating a quantitative result. The results are then interpreted by clinicians in the overall diagnostic process. The study evaluates the standalone performance of the reagents on the ACE Axcel Clinical Chemistry System.

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

The "ground truth" for this type of analytical validation is established by:

• Reference methods and/or the predicate device: For the matrix comparison, the serum measurements on the candidate device (which is substantially equivalent to the predicate) serve as the reference against plasma measurements. The predicate device's performance also implicitly serves as a benchmark for comparison.
• Known concentrations: For precision studies, samples are "clinically relevant decision levels" meaning they have known or well-characterized concentrations of the analytes. These concentrations are typically determined by highly accurate laboratory methods.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set. The reagents are chemical formulations, and the system is an automated analyzer.

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

Not applicable, as there is no training set for this type of device.

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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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