(48 days)
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System.
The Enzyme 2 Calibrator is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from porcine heart. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 1.5 mL.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 CAL - KC320), formatted as requested:
Acceptance Criteria and Study for Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 CAL - KC320)
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life Stability | Percent change over time should be ≤ 5% (when compared to control at -70°C). | Determined to be 12 months when stored at 4℃. The actual shelf-life dating at commercialization reflects real-time data. |
| On-Board Stability | Not explicitly stated as a numerical criterion for acceptance in the document. | A vial punctured by the instrument and stored on board has a seven day stability claim. This implies that performance within acceptable limits (likely the ≤ 5% change, though not explicitly stated for this specific condition) is achieved for 7 days. |
| Opened Vial Stability (Recapped & Refrigerated) | Not explicitly stated as a numerical criterion for acceptance in the document. | A vial that is uncapped, recapped, and stored in a refrigerator (not on instrument) has a stability claim of 31 days. This implies that performance within acceptable limits (likely the ≤ 5% change, though not explicitly stated for this specific condition) is achieved for 31 days. |
| Traceability | Standardized to a master pool assigned by the Dimension® clinical chemistry system. | The assigned values of the Enzyme 2 Calibrator are standardized to a master pool that is assigned by the Dimension® clinical chemistry system. Manufacturer's verification process involves adding verified stock solution to a bovine serum albumin base, and the concentration of each level is verified on an instrument calibrated with an approved Master Pool. Master Pool values are assigned for each level on multiple Dimension® instruments. |
| Value Assignment | Calculated quantities of verified stock solution achieve target concentrations; verified on an instrument calibrated with an approved Master Pool. | To manufacture a calibrator lot, calculated quantities of a verified stock solution are added to a bovine serum albumin base at target concentrations. The concentration of each level is verified on an instrument calibrated with an approved Master Pool. The Master Pool values are assigned for each level on multiple Dimension® instruments. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the number of individual calibrator vials or batches used in the stability studies. It mentions "a quantity sufficient for multiple calibrations" being removed for the opened vial stability tests. This is a common practice for stability studies, where multiple units are tested over time.
- Data Provenance: The data is described as "real-time data on file at Dade Behring, Inc." This indicates the studies were prospective in nature, conducted by the manufacturer, Dade Behring Inc., in Newark, DE, USA.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not mention the use of human experts to establish ground truth for the performance characteristics of this calibrator device. Calibrator performance is typically assessed by instrumental measurements against established reference materials or methods, not by expert consensus.
4. Adjudication Method for the Test Set:
- None. As the device is a calibrator and its performance is evaluated by quantitative analytical methods and comparison to a Master Pool, an adjudication method involving human interpretation is not applicable or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not applicable for a diagnostic calibrator device. These studies are typically used for imaging or diagnostic interpretation devices where human readers assess cases. The calibrator's function is to standardize measurements, which is an analytical performance characteristic.
6. Standalone Performance:
- Yes. The performance characteristics described (stability, traceability, value assignment) represent the standalone performance of the calibrator device itself. These studies evaluate the calibrator's properties (e.g., how long it remains stable, how accurately its values are assigned) independent of a human operator's interpretation. The calibrator's "performance" is its ability to accurately set the measurement scale for the Dimension Vista™ System.
7. Type of Ground Truth Used:
- The ground truth used is primarily instrumental measurement against a Master Pool. Specifically:
- For stability, results are compared to a "control stored at -70℃" which serves as a stable reference.
- For traceability and value assignment, the calibrator is standardized to a "Master Pool that is assigned by the Dimension® clinical chemistry system." The Master Pool itself would have its values established through a rigorous process, likely involving primary reference materials or highly accurate reference methods. This indicates a hierarchical traceability chain where the Master Pool is the ultimate "ground truth" reference for this specific system.
8. Sample Size for the Training Set:
- The concept of a "training set" is not applicable for this device. This is a calibrator, not an algorithm or an AI model that requires a training set for machine learning. Its manufacturing process involves adding stock solutions and verifying concentrations, not learning from data.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for this calibrator device, no ground truth for a training set was established.
§ 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.