(59 days)
Intended Use: For the quantitative determination of α-Amylase activity in human serum or plasma.
Indications for Use: Levels of serum and plasma α-amylase in patients have provided needed evidence for the diagnosis of acute pancreatitis. For In Vitro Diagnostic Use.
The Genzyme Direct Amylase Reagent is a quantitative method for the detection of a-amylase activity in serum and plasma.
Here's an analysis of the provided text regarding the Genzyme Direct Amylase Reagent, focusing on acceptance criteria and supporting studies:
Product Name: Genzyme Direct α-Amylase Test Reagent
Common Name: Reagent for α-Amylase Test
Intended Use: For the quantitative determination of α-Amylase activity in human serum or plasma for the diagnosis of Pancreatitis.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for each metric (e.g., "The slope must be between X and Y"). Instead, it presents the results of the performance studies and then concludes that these results are "acceptable" or "excellent," implying that the observed performance met their internal criteria. Based on the provided text, the acceptance criteria are inferred from these conclusions.
| Acceptance Criterion (Inferred) | Reported Device Performance | Study Conclusion |
|---|---|---|
| Comparative Performance | ||
| Correlation Coefficient (r) | 0.9985 | Acceptable correlation with predicate method. |
| Slope | 0.90 | |
| Intercept (U/L) | -2.50 | |
| Linearity | Linearity up to 2000 U/L | Demonstrated linearity. |
| Precision | ||
| Within-Run CV | ≤ 2.0% | Excellent within-run precision. |
| Between-Run CV | ≤ 2.0% | Excellent between-run precision. |
| Interference | No interference found at tested concentrations. | |
| Liposyn | 3000 mg/dL (1%) | |
| Triglyceride | 3000 mg/dL | |
| Ascorbic Acid | 50 mg/dL | |
| Bilirubin (unconjugated) | 50 mg/dL | |
| Bilirubin (conjugated) | 50 mg/dL | |
| Hemoglobin | 500 mg/dL | |
| Glucose | 2000 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size (Test Set):
- Comparative Performance Study: 50 samples
- Linearity Study: Not specified, but data points would typically cover the range up to 2000 U/L.
- Precision Studies (Within-Run & Between-Run):
- Within-Run: Each of 3 serum pools tested 20 times. (3 pools * 20 tests = 60 measurements)
- Between-Run: Each of 3 serum pools tested in duplicate, twice per day, for at least five days, totaling 40 determinations per pool. (3 pools * 40 measurements = 120 measurements)
- Interference Studies: "a specimen pool" was used, with varying levels of interferents added. Specific number of test samples per interferent not specified beyond "a specimen pool."
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Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it's typically for the US market, but the sample origin is not stated. The studies are prospective in nature, as they are specifically conducted to evaluate the performance of the Genzyme Direct Amylase Reagent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of in-vitro diagnostic (IVD) device for quantitative biochemical measurement does not typically involve human expert readers for establishing "ground truth" in the same way imaging devices do.
- For the Comparative Performance Study, the "ground truth" is defined by the results obtained from the predicate method (Roche Boehringer Mannheim α-Amylase/EPS) using the same 50 samples. This is a comparison against a legally marketed and accepted method, not expert consensus on qualitative interpretation.
- For Linearity, Precision, and Interference Studies, the "ground truth" is established by the inherent properties of the samples themselves (known concentrations, spiked interferents, etc.) as measured by the device and the reference methods used to prepare or characterize those samples (e.g., gravimetric for spiking, reference methods for initial concentrations). There are no "experts" establishing image interpretations or diagnoses.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative IVD performance study. Adjudication methods (e.g., 2+1, 3+1) are typically used when subjective review or interpretation by multiple human experts is involved, such as in clinical trials evaluating diagnostic accuracy of imaging or pathology results. The performance is assessed through statistical comparisons to a reference method or known values.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of an AI-assisted tool on human reader performance, common in radiology or pathology. The Genzyme Direct Amylase Reagent is a standalone in-vitro diagnostic assay; it does not involve human readers interpreting results in a subjective or diagnostic manner that would be "assisted" by the device in the context of an MRMC study. Its performance is measured directly (e.g., U/L) and compared to another quantitative method.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the entire series of studies described (Comparative Performance, Linearity, Precision, Interference) are essentially standalone performance studies for the Genzyme Direct Amylase Reagent. The device itself is the algorithm/method being evaluated, and its performance is measured directly from the assay results without human interpretative input in the loop for the performance metrics.
7. The Type of Ground Truth Used
- Comparative Performance Study: The ground truth was the measurements obtained from the predicate method (Roche Boehringer Mannheim α-Amylase/EPS). This is a reference method comparison.
- Linearity Study: The ground truth was based on the known dilution series or spiked concentrations of α-amylase, demonstrating the device's ability to accurately measure over a range.
- Precision Study: The ground truth was the mean concentration of α-amylase within the serum pools, with the study assessing the device's variability around that mean.
- Interference Study: The ground truth was the known concentrations of purified interfering substances (e.g., Liposyn, Triglyceride, etc.) added to a specimen pool. The goal was to show that these known interferents did not affect the amylase measurement.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI algorithms that would require one. The Genzyme Direct Amylase Reagent appears to be a traditional biochemical reagent-based assay, not an AI/ML powered device. Its "learning" comes from its chemical formulation and calibration, not from data-driven training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of traditional IVD device, this question is not applicable.
§ 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.