Search Results

The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum 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 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 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 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 Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Cholesterol Reagent assay, cholesterol esters in serum 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 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 sub- strates, 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.

Here's an analysis of the acceptance criteria and study details for the Alfa Wassermann ACE Axcel Clinical Chemistry System and its associated reagents, based on the provided 510(k) summary:

Overview of Device and Study Purpose:

This submission describes the ACE Axcel Clinical Chemistry System and four associated reagents (ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, ACE Triglycerides Reagent). The study's primary purpose is to demonstrate the substantial equivalence of the new ACE Axcel System and its reagents to predicate devices (Alfa Wassermann ACE plus ISE/Clinical Chemistry System and its reagents) by showing comparable performance in terms of precision, accuracy, and detection limits.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the typical expectations for clinical chemistry analyzers. The document focuses on demonstrating that the new system's performance is equivalent or better than the predicate.

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

• ACE Cholesterol Reagent (Accuracy): 110 samples.
• ACE HDL-C Reagent (Accuracy): 109 samples.
• ACE LDL-C Reagent (Accuracy): 108 samples.
• ACE Triglycerides Reagent (Accuracy): 111 samples.

The samples for the accuracy ("correlation") studies were assayed on both the new ACE Axcel System (y) and the predicate Alfa Wassermann ACE Clinical Chemistry System (x).

Data Provenance: The document does not explicitly state the country of origin. The studies were conducted at a main lab and three separate Physician Office Laboratory (POL) sites, suggesting real-world clinical samples. There is no indication of whether the data was retrospective or prospective, but given the nature of a comparability study for a new device, it is typically prospective, involving fresh samples run on both systems simultaneously.

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

This type of device (clinical chemistry analyzer) does not typically involve human experts establishing ground truth in the way radiological or pathological devices do. The "ground truth" for the test set is established by the predicate device (Alfa Wassermann ACE Clinical Chemistry System) itself, which is assumed to be accurate and clinically acceptable. The study's goal is to show agreement with this established method. Therefore, no external human experts are used for ground truth establishment for individual samples.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is a quantitative comparison study against a predicate device, not an interpretation-based study requiring expert adjudication of results. The predicate device's readings serve as the comparator.

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 for an automated clinical chemistry analyzer which provides quantitative measurements, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the studies presented are generally "standalone" in the sense that they evaluate the performance of the automated ACE Axcel Clinical Chemistry System (device and reagents) directly. The system provides quantitative results, and the performance metrics (precision, accuracy, detection limit) are intrinsic to the device's operation. There isn't a human-in-the-loop component being evaluated for diagnostic decision-making, rather the system is automated to provide a numerical result.

7. The Type of Ground Truth Used

The ground truth used for accuracy (correlation) studies is the measurement obtained from the predicate device, the Alfa Wassermann ACE Clinical Chemistry System. This is a common approach for demonstrating substantial equivalence for clinical chemistry analyzers, where the new device's performance is compared against another legally marketed device's performance.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a clinical chemistry system and its reagents, not an AI/ML algorithm that typically requires a separate training set. The "training" for such systems would involve chemical formulation and instrument calibration, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the instrument and formulation of reagents are based on established chemical and engineering principles rather than data-driven ground truth for machine learning.

Ask a specific question about this device