(15 days)
ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems AMYLASE SL is available as kit only. It consists of one reagent R whose the composition is: MES buffer (pH 6.15), sodium chloride, calcium chloride, potassium thiocyanate, CNP-G3 (2-chloro-4-nitrophenyl-α-maltotrioside), sodium azide.
ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
1. Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Guidelines) | Reported Device Performance (ELITech Clinical Systems AMYLASE SL) |
|---|---|---|
| Precision | ||
| Within-run CV% | Not explicitly stated, but generally 0.975) and acceptable bias (slope close to 1, intercept close to 0) | y = 0.976 x -1 U/L; r = 0.999; r2 = 0.999; Sy.x = 10 U/L |
| Plasma Comparison (Correlation with serum) | Strong correlation (r > 0.975) and acceptable bias (slope close to 1, intercept close to 0) | y = 0.907 x + 1 U/L; r = 1.000; r2 = 1.000; Sy.x = 6 U/L |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set: 80 measurements for each of 3 levels (total of 240 measurements) were taken.
- Linearity Test Set: The number of samples for the linearity study is not specified, but the study was conducted according to CLSI protocol EP6-A.
- Detection Limit (LoD & LoQ) Test Set: 15 measurements for each of 4 samples with low concentration of analyte (total 60 measurements)
- Interference Test Set: The number of unique samples is not specified, but various substances were tested at specified concentrations.
- Method Comparison Test Set: 100 serum patient samples.
- Plasma Comparison Test Set: 48 paired plasma (in lithium heparin) samples.
- Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective analytical performance studies conducted by the device manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For in vitro diagnostic devices like the ELITech Clinical Systems AMYLASE SL, "ground truth" for analytical performance studies is typically established by comparing results to well-defined reference methods, predicate devices, or by preparing samples with known concentrations. The document does not mention the involvement of "experts" in the context of establishing ground truth in the way it might apply to image-based diagnostic AI. Instead, it relies on established laboratory procedures and reference standards.
- The "IFCC method" is mentioned as the traceability standard for the calibrator, which implies a highly standardized and internationally recognized reference for amylase measurement. The reference range also cites a publication by G. Schumann et al. on IFCC Primary Reference Procedures.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative diagnostic tests where human interpretation is involved. For this quantitative in vitro diagnostic device, such an adjudication method is not relevant or mentioned. The performance is assessed by comparing quantitative results to reference methods, predicate devices, or known values, which is inherently objective and does not require adjudication in the human interpretative sense.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for image-based diagnostics or other tests heavily reliant on human interpretation, often to quantify the improvement in human reader performance with AI assistance. This device is a quantitative clinical chemistry assay, not an AI-assisted diagnostic.
6. Standalone Performance Study
- Yes, the performance characteristics (precision, linearity, detection limits, interference, method comparison) described are all standalone (algorithm only) performance studies of the device (AMYLASE SL reagent on the Selectra ProM analyzer). The device itself is an automated assay, and its performance is evaluated independent of human interpretation or intervention beyond standard laboratory procedures.
7. Type of Ground Truth Used
- Precision: Internal controls and samples with known or characterized concentrations.
- Linearity: Samples prepared with varying, known concentrations.
- Traceability: Traceable to the IFCC method.
- Stability: Measured over time using internal controls and reference materials.
- Detection Limit (LoD) & Quantification Limit (LoQ): Calculated based on repeated measurements of low-concentration samples.
- Interference: Samples spiked with known interferents at specified concentrations.
- Method Comparison: Comparison against a legally marketed predicate device (Roche Diagnostics AMYL2 on cobas c111 analyzer) using patient samples. This serves as a comparative ground truth.
- Plasma Comparison: Comparison between serum and lithium heparin plasma samples from the same patients.
8. Sample Size for the Training Set
- This device is a reagent for a clinical chemistry assay, not an AI/ML algorithm that requires a "training set" in the conventional sense. The development of such assays involves extensive R&D and optimization, but not typically a labeled "training set" of data for algorithm learning.
9. How the Ground Truth for the Training Set Was Established
- As stated above, the concept of a "training set" and associated "ground truth" establishment for algorithm learning does not apply to this type of in vitro diagnostic device. The development and validation process relies on established analytical chemistry principles and performance testing against recognized standards and methods.
§ 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.