(84 days)
The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® AND LX™ Clinical Systems. The SYNCHRON Systems Lipase (LIPA) Reagent, when used in coniunction with SYCNRHON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
The provided text describes the performance data for the SYNCHRON Systems Lipase (LIPA) Reagent. Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" but presents performance data that would be used to demonstrate substantial equivalence. The predicate device is the SYNCHRON Systems Lipase Reagent on the CX System. The new device is the SYNCHRON Systems Lipase Reagent on the LX System.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (SYNCHRON Systems Lipase Reagent on the LX System) |
|---|---|---|
| Method Comparison vs. Predicate | (Compared to SYNCHRON Systems Lipase Reagent on the CX System) | |
| Slope | Close to 1.000 | 1.068 |
| Intercept | Close to 0 U/L | -0.42 U/L |
| Correlation Coefficient (r) | Close to 1.000 | 0.997 |
| Measuring Range (Linearity) | ||
| Default Measuring Range | Linear - 5-600 U/L | Linear - 5-600 U/L |
| ORDAC Measuring Range | Linear - 480-1200 U/L | Linear - 480-1200 U/L |
| Imprecision (Within-Run) | ||
| Level 1 %C.V. | Low variability | 1.38% |
| Level 2 %C.V. | Low variability | 1.54% |
| Level 3 %C.V. | Low variability | 7.18% |
| Imprecision (Total) | ||
| Level 1 %C.V. | Low variability | 2.28% |
| Level 2 %C.V. | Low variability | 2.24% |
| Level 3 %C.V. | Low variability | 9.77% |
2. Sample size used for the test set and the data provenance:
- Sample Size for Method Comparison: 91 samples (n=91) were used for the method comparison study between the SYNCHRON Systems Lipase Reagent on the LX System and the predicate system (SYNCHRON Systems Lipase Reagent on the CX System).
- Sample Size for Imprecision: 80 samples (n=80) were used for each of the three levels of imprecision testing (within-run and total imprecision).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be internal testing conducted by Beckman Instruments, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is an in vitro diagnostic (IVD) device for quantitative biochemical measurement, not an AI or imaging device requiring expert interpretation for ground truth. The "ground truth" for this device is the actual lipase activity in the samples, determined by the predicate device or a reference method.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3. Adjudication usually pertains to discrepancies in human interpretation, which is not relevant here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This is an IVD device for automated quantitative analysis, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance reported is inherently "standalone" in the context of an automated IVD chemistry analyzer. The SYNCHRON Systems Lipase Reagent on the LX System performs the quantitative determination of pancreatic lipase activity without human involvement in the measurement process itself, beyond loading samples and calibrators. The reported slope, intercept, correlation, and imprecision are characteristics of the reagent and analyzer system.
7. The type of ground truth used:
The ground truth for the method comparison study was established by the predicate method, specifically the "SYNCHRON Systems Lipase Reagent on the CX System." For linearity and imprecision studies, the "ground truth" would be established by the known concentrations/activities of quality control materials or reference methods.
8. The sample size for the training set:
This information is not applicable. This IVD device is a chemical reagent and an analyzer system, not a machine learning or AI model that requires a "training set" in the computational sense. The performance characteristics are derived from chemical reactions and instrument calibration.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
§ 862.1465 Lipase test system.
(a)
Identification. A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.