(82 days)
The Compass Bioscience Cardiac Markers Controls are to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control. It is intended to validate the measurement of these analytes in patient samples.
Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.
The Compass Bioscience Cardiac Marker Calibration Control Set is used to verify the calibration of various test methods over the measurable range of the test.
Compass Bioscience Cardiac Markers Controls are supplied in three levels, 2 x 1 mL each level per box and as a four Level Calibration Verification set, 2 x 1 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human EDTA plasma matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the levels. Sodium Azide
Here's a breakdown of the acceptance criteria and the study details for the Compass Bioscience Cardiac Markers Control and Calibration Verification Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Closed Vial Stability (-20°C) | Analyte recovery within ±(10% + highest allowable instrument/reagent imprecision) compared to initial test value after 1 year simulated storage | Passed: Achieved 1-year stability, based on accelerated stability studies by storing at 2-8°C to simulate -20°C conditions. Real-time testing is ongoing. |
| Closed and Opened Vial Stability (2-8°C) | Analyte recovery within ±(10% + % CVmethod) compared to Day 0 value after: |
- 30 days for CK-MB and Myoglobin
- 14 days for Troponin I and BNP | Passed: Achieved 30-day stability for CK-MB and Myoglobin, and 14-day stability for Troponin I and BNP. Testing was conducted by measuring recovery at 7-day intervals. |
| Consistency Across Lots | No significant difference in performance across multiple lots of product. | Passed: Multiple lots of product were tested with no significant difference in performance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For stability testing, "multiple lots of product" were used. The exact number of lots is not specified.
- For establishing assayed values, "multiple instruments and reagent lots" were used for calculations. The exact number is not explicitly stated.
- Data Provenance: The studies appear to be prospective as they involve real-time and accelerated stability testing of manufactured product lots. The data was generated in-house at Compass Bioscience and through interlaboratory studies. The country of origin of the data is not specified, but the manufacturing company (Compass Bioscience) is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The term "ground truth" isn't directly applicable in the context of control materials in the same way it would be for a diagnostic device identifying disease.
- For establishing "Assayed Values" (which serve as the reference for the control material), values were determined:
- From assays performed in the Compass Bioscience laboratory using three Triage® MeterPlus readers with specific Triage® panel tests.
- From interlaboratory data using instrument manufacturers' reagents.
- The text doesn't specify the "number of experts" or their "qualifications" in the traditional sense. Rather, it describes a process of analytical measurement using standard laboratory equipment and interlaboratory comparison.
4. Adjudication Method for the Test Set:
- No specific adjudication method (like 2+1, 3+1, none) is described for the test set or for establishing the assayed values. The values were derived from direct measurement and interlaboratory consensus on those measurements.
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 typically evaluates the improvement in human reader performance (e.g., radiologists interpreting images) with and without AI assistance for diagnostic tasks. This device is a quality control material, not a diagnostic imaging or interpretive AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable to this device. The Compass Bioscience Cardiac Markers Control and Calibration Verification Set is a laboratory reagent (control material), not an algorithm or AI software. Its performance is evaluated based on its stability and its ability to provide consistent, established analyte levels when tested on laboratory instruments.
7. The Type of Ground Truth Used:
- As mentioned in point 3, the concept of "ground truth" as a diagnostic outcome is not strictly applicable.
- The "ground truth" for the control material itself is its established assayed values, which are derived from:
- Expert consensus/analytical measurement: Assays performed in-house using multiple instruments (Triage® MeterPlus readers) and specific test panels.
- Interlaboratory data: Data obtained from other laboratories using various instrument manufacturers' reagents.
- These values form the reference against which other measurements (e.g., during stability testing or routine QC) are compared.
8. The Sample Size for the Training Set:
- This question is not applicable to this device. As a control material, it does not use a "training set" in the context of machine learning or algorithm development. The "training" in this context would refer to the process of establishing the assayed values for the control material, as described in point 7.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no "training set" for an algorithm. However, if we interpret "ground truth for the training set" as "how the assayed values for the control material were established," then:
- Assayed values for package inserts were established by:
- Performing assays in the Compass Bioscience laboratory using three Triage® MeterPlus readers with the Triage® Profiler S.O.B.™ Panel tests, the Triage® CardioProfiler Panel, and the Triage® Cardiac Panel.
- Collecting and analyzing interlaboratory data using various instrument manufacturers' reagents.
- Mean values were calculated from multiple instruments and reagent lots.
- Ranges were determined based on 2 SD - 3 SD of the overall mean values derived from stability and interlaboratory data.
- Assayed values for package inserts were established by:
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.