(26 days)
Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems.
The Lipoprotein Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bayer Healthcare Lipoprotein Calibrator:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's stability as a key performance characteristic and compares it to a predicate device, rather than explicit numerical acceptance criteria.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Bayer Lipoprotein Calibrator) | Predicate Device Performance (Bayer SETpoint™ Calibrator) |
|---|---|---|---|
| Intended Use | Calibrate Apolipoprotein A1 and Apolipoprotein B assays on ADVIA IMS Chemistry systems. | Intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on ADVIA IMS Chemistry systems. | For use as a calibrator of clinical chemistry assays for automated analytical procedures. |
| Format | Lyophilized human/bovine serum base with appropriate human constituents for specific concentrations. | Lyophilized mixture of human and bovine serum base to which appropriate human constituents have been added to achieve specific concentrations. | Lyophilized bovine serum base to which appropriate nonhuman constituents have been added to achieve specific concentrations. |
| Stability (Unreconstituted) | Stable at 2-8°C until expiration date. | Stable at 2-8°C until the expiration date printed on label. | Stable at 2-8°C until last day of the month (expiration date) printed on the label. |
| Stability (Reconstituted) | Stable for a defined period when refrigerated at 2-8°C according to directions. | Stable 3 days when reconstituted according to directions when refrigerated at 2-8°C. | Stable 48 hours when reconstituted according to directions when refrigerated at 2-8°C and protected from light (with exceptions for bilirubin). |
| Levels | Single Level Calibration. | Single Level | Single Level |
Study Proving Acceptance Criteria:
The document states: "The stability of the Lipoprotein calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use."
This indicates an internal validation study was performed by Bayer, focusing on the stability of the calibrator over time and under specified conditions, using multiple manufacturing lots.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "three separate lots of calibrator material." This refers to the manufacturing lots of the calibrator itself, not patient samples or a test set in the traditional sense for diagnostic accuracy.
- Data Provenance: The data was generated by Bayer Healthcare. The country of origin is not explicitly stated for the testing, but Bayer Healthcare is a global company. The study is prospective in nature, as it involves testing the stability of newly manufactured calibrator lots.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this device. This device is a calibrator, meaning its "truth" is its measured concentration of specified analytes (Apolipoprotein A1 and B) which it is designed to maintain. The "ground truth" would be established by analytical methods to determine the target concentrations of these analytes within the calibrator material, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" in the sense of patient data requiring adjudication. The performance evaluation focuses on the analytical stability of the calibrator itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a calibrator, not an imaging or diagnostic device that requires human interpretation or comparison against other diagnostic methods in a clinical setting.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical calibrator for laboratory assays, not a software algorithm. Its "performance" refers to its ability to maintain stable and accurate assigned values for calibrating other instruments.
7. Type of Ground Truth Used:
The ground truth for this device (a calibrator) would be the analytically determined concentration values of Apolipoprotein A1 and Apolipoprotein B within the calibrator material. These values are established through rigorous reference methods and material characterization during the manufacturing and quality control processes.
8. Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or an "algorithm" requiring a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.