(109 days)
The Amylase assay is used for the quantitation of amylase in serum, plasma, or urine on the AEROSET System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Amylase is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine. The Amylase assay is a clinical chemistry assay. The amylase in the sample hydrolyzes the 2-chloro-4-nitrophenyl-alpha-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenyl-alpha-D-maltoside (CNPG2), maltotriose (G3), and glucose (G). The rate of formation of the 2-chloro-4-nitrophenol is measured as an increase in the absorbance at 405 nm and is directly proportional to the activity of amylase present in the sample.
The Abbott Laboratories "Amylase" assay (Amy) is used for the quantitative determination of amylase in serum, plasma, or urine on the AEROSET System, primarily for the diagnosis and treatment of pancreatitis.
Here's a breakdown of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Amy on AEROSET) |
|---|---|---|
| Correlation to Predicate (Serum) | Acceptable correlation with Boehringer Mannheim α-Amylase/EPS assay (K882225) on Hitachi 717 Analyzer | Correlation coefficient (r) = 0.9990, Slope = 1.237, Y-intercept = -1.232 U/L |
| Correlation to Predicate (Urine) | Acceptable correlation with Boehringer Mannheim α-Amylase/EPS assay (K882225) on Hitachi 717 Analyzer | Correlation coefficient (r) = 0.9963, Slope = 1.042, Y-intercept = 2.102 U/L |
| Precision (Serum, Level 1) | Not explicitly stated but implied to be low CV% | Total %CV for Level 1/Panel 101 = 1.0% |
| Precision (Serum, Level 2) | Not explicitly stated but implied to be low CV% | Total %CV for Level 2/Panel 102 = 1.6% |
| Precision (Urine, Level 1) | Not explicitly stated but implied to be low CV% | Total %CV for Level 1/Panel 201 = 1.3% |
| Precision (Urine, Level 2) | Not explicitly stated but implied to be low CV% | Total %CV for Level 2/Panel 202 = 1.1% |
| Linearity / Assay Range | Not explicitly stated but implied to be comparable to predicate | Linear up to 3010.3 U/L |
| Limit of Quantitation (Sensitivity) | Not explicitly stated but implied to be comparable to predicate | 1.8 U/L |
Note: The document describes "acceptable correlation" as the acceptance criterion for the comparison studies. The specific numerical thresholds for correlation coefficient, slope, and intercept were not explicitly defined as acceptance criteria but are presented as the results that demonstrated "acceptable correlation" compared to the predicate device. Similarly, for precision, linearity, and sensitivity, specific acceptance criteria in terms of numerical ranges were not provided in the summary, but the reported performance values are presented as meeting the implied standard of "substantially equivalent" to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for the comparative performance studies or the precision studies.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It states that "comparative performance studies were conducted" and "precision studies were conducted," implying these were experimental studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic assay that quantifies amylase levels. The "ground truth" for the test set in this context would be the results obtained from the predicate device (Boehringer Mannheim α-Amylase/EPS assay on the Hitachi 717 Analyzer) against which the new device was compared. This is a comparison between two quantitative assays, not an expert-based diagnostic ground truth.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation involves comparing quantitative results from two analytical devices, not adjudication by human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is an in vitro diagnostic assay, not an imaging device requiring human reader interpretation or an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is effectively a standalone performance evaluation. The "Amy" assay on the AEROSET System is an automated analytical system that quantitatively measures amylase. Its performance characteristics (correlation, precision, linearity, sensitivity) were evaluated directly, without human interpretation as part of the primary diagnostic output.
7. The Type of Ground Truth Used
The "ground truth" for the comparative effectiveness study (which establishes substantial equivalence) was the measurements obtained from the legally marketed predicate device: the Boehringer Mannheim α-Amylase/EPS assay (K882225) on the Hitachi 717 Analyzer.
8. The Sample Size for the Training Set
Not applicable. This is a classic in vitro diagnostic device, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. The device's calibration and method development would involve internal studies, but these are distinct from a "training set" for AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.