(14 days)
For determination of the instrument specific Direct Amylase reagent factor for analyzers using Genzyme Direct Amylase Reagent.
The Genzyme Direct Amylase Verifier is intended to be used as a companion product with the Genzyme Direct Amylase reagent manufactured by Genzyme but sold separately. The product is buffer formulated with human amylase and preservative. The Verifier values are in the clinically relevant range of 200 U/L to 275 U/L. The Direct Amylase Verifier is for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. It is possible this Verifier would need to be used again if significant maintenance was performed on the analyzer and this is addressed in the Direct Amylase Verifier product labeling.
Here's a breakdown of the acceptance criteria and study information for the Genzyme Direct Amylase Verifier, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to the legally marketed predicate device: The Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer. | The Genzyme Direct Amylase Verifier used with the Genzyme Direct Amylase reagent on other analyzers performs substantially equivalent to the Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer. |
| The device should serve as a calibrator for the Genzyme Direct Amylase assay. | The Genzyme Direct Amylase Verifier is intended to be used as a companion product with the Genzyme Direct Amylase reagent... for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. |
| The Verifier values should be in a clinically relevant range. | The Verifier values are in the clinically relevant range of 200 U/L to 275 U/L. |
| The device should be able to confirm the correct enzyme factor on a clinical chemistry analyzer when used with the Genzyme Direct Amylase reagent. | It is for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. |
Study Information:
- Study Description: The provided text mentions "results obtained in Genzyme's testing" to demonstrate substantial equivalence. However, it does not provide details about the specific study design, methodology, or results beyond the general statement of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The text states "results obtained in Genzyme's testing," implying that the data was generated internally by Genzyme. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the device is a calibrator for a diagnostic assay, and its performance is typically evaluated against analytical standards or a predicate device's measured values, rather than human expert interpretation of a diagnostic output.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided as the device is a calibrator and does not involve human interpretation or adjudication for its performance evaluation in the context described.
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 typically used for diagnostic devices that involve human interpretation of images or other complex outputs to assess the impact of AI assistance on human reader performance. The Genzyme Direct Amylase Verifier is a calibrator for a biochemical assay and does not involve such a process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, a standalone performance was done for the calibrator. The "Genzyme's testing" that demonstrated substantial equivalence would have evaluated the calibrator's performance analytically in its intended use, which is an "algorithm only" type of evaluation in this context (i.e., the calibrator's ability to produce correct values on an analyzer independently of human interpretation).
7. The Type of Ground Truth Used
- The ground truth in this context would likely be established analytical values or a reference standard for amylase activity, against which measurements obtained using the Genzyme Direct Amylase Verifier are compared. The text mentions it is a "buffer formulated with human amylase," suggesting a known concentration of amylase. The comparison is made to the performance of the "Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer," which serves as the predicate device and thus its performance acts as a reference.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Genzyme Direct Amylase Verifier is a physical calibrator product, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as the device is not an AI/ML algorithm that uses a training set.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.