(66 days)
The Amylase assay is used for the quantitation of amylase in human serum, plasma, or urine. 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-a-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenylα-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 is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine, used primarily for the diagnosis and treatment of pancreatitis. The assay measures the rate of formation of 2-chloro-4-nitrophenol, which is directly proportional to the amylase activity.
The device's performance was compared to the Roche Cobas Mira Plus Automated Chemistry System Amylase assay (K903309) for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (from predicate K903309) | Reported Device Performance (Amylase assay) |
|---|---|---|
| Correlation Coefficient (Serum) | Not explicitly stated, but "similar performance characteristics" is implied. | 0.9791 |
| Slope (Serum) | Not explicitly stated, but "similar performance characteristics" is implied. | 1.126 |
| Y-intercept (Serum) | Not explicitly stated, but "similar performance characteristics" is implied. | -18.427 U/L |
| Correlation Coefficient (Urine) | Not explicitly stated, but "similar performance characteristics" is implied. | 0.9702 |
| Slope (Urine) | Not explicitly stated, but "similar performance characteristics" is implied. | 0.977 |
| Y-intercept (Urine) | Not explicitly stated, but "similar performance characteristics" is implied. | 0.447 U/L |
| Total %CV (Serum, Level 1) | Not explicitly stated, but "similar performance characteristics" is implied. | 3.3% |
| Total %CV (Serum, Level 2) | Not explicitly stated, but "similar performance characteristics" is implied. | 3.7% |
| Total %CV (Urine, Level 1) | Not explicitly stated, but "similar performance characteristics" is implied. | 10.6% |
| Total %CV (Urine, Level 2) | Not explicitly stated, but "similar performance characteristics" is implied. | 4.4% |
| Linearity (Upper Limit) | Not explicitly stated, but "similar performance characteristics" is implied. | 2,500 U/L |
| Limit of Quantitation (Sensitivity) | Not explicitly stated, but "similar performance characteristics" is implied. | 4.268 U/L |
Study Proving Acceptance Criteria:
Comparative performance studies were conducted using the ALCYON™ Analyzer to demonstrate substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of samples used for the comparative performance studies (method comparison and precision studies).
- Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study, comparing the performance of the new Amylase assay with an existing, legally marketed device using collected data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is an in vitro diagnostic device for quantitative chemical analysis. The "ground truth" is established through the measured values of the predicate device (Roche Cobas Mira Plus Automated Chemistry System Amylase assay) against which the new device's performance is compared, and through control materials for precision studies. No human experts are involved in establishing the ground truth for this type of quantitative assay performance study.
4. Adjudication method for the test set:
Not applicable. As described above, this is a quantitative chemical assay, and the "ground truth" is derived from the predicate device and control materials, not expert adjudication.
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 an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or human-read interpretation device. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance characteristics presented are for the Amylase assay in a standalone algorithm-only manner, running on the ALCYON™ Analyzer. The comparison is between two automated assay systems.
7. The type of ground truth used:
The ground truth for the comparison study is the quantitative results obtained from the predicate device (Roche Cobas Mira Plus Automated Chemistry System Amylase assay). For precision studies, the ground truth is the expected values of the control materials.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-driven device that requires a "training set" in the conventional sense. The device's calibration and method development are based on established chemical principles and manufacturer-specific optimization processes, not on training data sets.
9. How the ground truth for the training set was established:
Not applicable, as explained in 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.