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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 Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum using the ACE Axcel Clinical Chemistry System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Axcel Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. 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 Alkaline Phosphatase Reagent assay, alkaline phosphatase in serum catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.

In the ACE AST Reagent assay, a-amylase hydrolyzes the 2-chloro-p- nitrophenyl-a-D-maltotrioside substrate to release 2-chloro-p- nitrophenol and form 2-chloro-p- nitrophenyl-a-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the a- amylase activity in the sample.

In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L- lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for ACE Alkaline Phosphatase, Amylase, and LDH-L Reagents on the ACE Axcel Clinical Chemistry System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents, K931786) by showing a high degree of correlation and acceptable precision. The reported device performance is compared to the predicate device.

ACE Alkaline Phosphatase Reagent

ACE Amylase Reagent

ACE LDH-L Reagent

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

• ACE Alkaline Phosphatase Reagent:

  • Accuracy (Correlation Study): 112 samples.
  • Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
  • Precision (Central Lab): Data collected over 22 days, with 4 alkaline phosphatase levels tested. The exact number of individual samples run per level/day is not specified but is typical for precision studies (e.g., n=2 or n=3 replicates).
  • Precision (POL Sites): Data collected over 5 days at 3 separate Physician Office Laboratories (POLs), with 4 alkaline phosphatase levels tested. The exact number of individual samples run per level/day is not specified.
  • Data Provenance: Not explicitly stated, but the mention of "Central Lab" and "Physician Office Laboratory (POL) sites" suggests clinical laboratory settings. It does not specify country of origin or if retrospective/prospective, but stability studies and clinical accuracy studies usually involve prospective collection or use of banked clinical samples. Given it is a 510(k) submission, it is likely representing real-world clinical samples.

• ACE Amylase Reagent:

  • Accuracy (Correlation Study): 111 samples.
  • Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
  • Precision (Central Lab): Data collected over 22 days, with 4 amylase levels tested.
  • Precision (POL Sites): Data collected over 5 days at 3 separate POL sites, with 4 amylase levels tested.
  • Data Provenance: Similar to Alkaline Phosphatase, suggesting clinical laboratory settings in the US, likely using prospective or banked clinical samples.

• ACE LDH-L Reagent:

  • Accuracy (Correlation Study): 121 samples.
  • Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
  • Precision (Central Lab): Data collected over 22 days, with 4 LDH levels tested.
  • Precision (POL Sites): Data collected over 5 days at 3 separate POL sites, with 4 LDH levels tested.
  • Data Provenance: Similar to the previous reagents, suggesting clinical laboratory settings in the US, likely using prospective or banked clinical samples.

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

This device is a clinical chemistry analyzer, not an imaging or diagnostic AI device that requires expert adjudication for "ground truth." The "ground truth" for the accuracy studies is established by the performance of the predicate device (Alfa Wassermann ACE Clinical Chemistry System). The predicate device itself would have been validated against established reference methods or clinical outcomes when it was initially cleared/approved. Therefore, no human experts directly establish "ground truth" in the way it might for image interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of device (clinical chemistry analyzer). Adjudication methods like 2+1 or 3+1 are used for subjective interpretations or classifications (e.g., by radiologists or pathologists) to reach a consensus "ground truth." For quantitative measurements, the "truth" is typically a measurement from a reference method or a well-established, previously validated method (in this case, the predicate device).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is typically for evaluating the performance of AI algorithms in conjunction with human readers, often in image interpretation tasks. This submission is for a clinical chemistry analyzer and reagents.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are essentially "standalone" performance evaluations of the new ACE Axcel Clinical Chemistry System with the specific reagents. The system measures analyte concentrations automatically, and its performance (precision, accuracy, detection limit) is assessed without direct human intervention in the measurement process itself, although human operators load samples and maintain the system. The "comparison" is to the predicate device, which is also a standalone automated system.

7. The Type of Ground Truth Used

The "ground truth" used for accuracy (correlation) studies is the measurement result from the legally marketed predicate device: the Alfa Wassermann ACE Clinical Chemistry System and its corresponding ACE Reagents (K931786). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a recognized gold standard method might not be readily available for routine testing or if the goal is to show equivalence to an existing market performer.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device is a traditional clinical chemistry analyzer based on established photometric and enzymatic reaction principles. The "training" for such a system would involve instrument calibration (which uses control materials, not a "training set" of patient data) and reagent manufacturing/quality control.

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

Not applicable, as there is no "training set" for an AI algorithm. For instrument calibration, the "ground truth" for calibrators would be established by the manufacturer using reference methods or certified reference materials, and then verified through quality control materials.

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