(14 days)
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm CK-MB is a lyophilized controls based on bovine serum albumin. Adjusted activities of the control components are usually in the normal range or at the normal/pathological threshold. Precipath CK-MB is a lyophilized controls based on bovine serum albumin. Adjusted activities of the control components are usually in the pathological range. Biological additives for both control levels include CK-MM from human origin and CK-BB from porcine brain.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Precinorm CK-MB & Precipath CK-MB controls, structured to meet your request.
Please Note: The provided document is a 510(k) summary for a "Special 510(k): Device Modification" for quality control materials. As such, it describes modifications to existing controls and their intended use in monitoring the accuracy and precision of other diagnostic methods. Therefore, the types of studies you'd typically see for a diagnostic device (e.g., clinical trials with human subjects, ground truth established by pathology or outcomes data) are not applicable here. Instead, the "device performance" relates to the control's ability to maintain its specified analyte levels and stability, and the "study" is more akin to a verification and validation of these characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria | Reported Device Performance/Study Findings |
|---|---|
| Intended Use: | |
| Precinorm CK-MB: monitoring accuracy and precision for quantitative methods (normal range or normal/pathological threshold). | |
| Precipath CK-MB: monitoring accuracy and precision for quantitative methods (pathological range). | The modifications (new name Precipath CK-MB with existing concentration, and new Precinorm CK-MB with reduced levels) are intended to continue to fulfill the use case of monitoring accuracy and precision for quantitative methods. The application emphasizes substantial equivalence to the predicate device in terms of intended use, with the primary change being the introduction of a control covering the normal range. |
| Analyte Level (Active Ingredient Level): | |
| Precinorm CK-MB: CK and CK-MB usually at normal range or at the normal/pathological threshold. | |
| Precipath CK-MB: CK and CK-MB usually at pathological level. | These are the stated characteristics of the modified devices. The value assignment process described below is the study that establishes these levels. |
| Stability (Shelf Life & Open Vial): | |
| 2-8 °C until expiration date | |
| Reconstituted: 24 hours at 25° C, 3 days at 4° C, 1 month at -20° C (freeze only once). | The "Same" entry in the "Modified device" column for stability and shelf life compared to the predicate device (K003158) indicates that the modified controls meet the same stability criteria as the predicate. The document implies that stability studies for the modified formulations confirmed these specifications, as it explicitly states the predicate's performance and then claims "Same" for the modified device. |
| Traceability of Target Values: | |
| Traceability given in instructions for use of the system reagent with recommended calibrator. | "Same" as the predicate device. This implies that the method for ensuring traceability of the assigned values to reference standards is consistent with the previously cleared device. |
| Value Assignment (Accuracy/Precision of Control Values): | |
| Set-point established via mean of at least three independent series in three internal laboratories, each with full calibration. | The "Value Assignment" process is detailed as: |
- Conducted in three internal laboratories.
- Each laboratory runs at least three independent series.
- An independent series includes full calibration using a new calibrator vial and sample vial.
- The mean of these measurements is used as the setpoint (assigned value) for the control.
- The master calibrator is used for calibration. This process ensures the accuracy and precision of the assigned values for the control material itself. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: For the "Value Assignment" study, the sample size is described as "at least three independent series" over "three internal laboratories." This means a minimum of 9 independent measurements (3 labs * 3 series/lab) would be performed to establish the mean setpoint for each control level (Precinorm CK-MB and Precipath CK-MB) and each analyte (CK and CK-MB).
- Data Provenance: The data is generated from prospective testing within Roche Diagnostics' internal laboratories. The country of origin is not explicitly stated, but Roche Diagnostics is headquartered in Switzerland, with the submitting entity located in Indianapolis, IN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: This isn't applicable in the traditional sense of human expert review for "ground truth" for a diagnostic device. The "ground truth" here is the assigned value of the control material, representing a specific and known concentration of the analyte.
- Qualifications of Experts: The "experts" involved are the laboratory personnel performing the "Value Assignment" in the three internal laboratories. Their qualifications are implied by their ability to operate the analytical instruments, perform calibrations, and execute the value assignment protocol according to internal standards and good laboratory practices. The document does not specify individual qualifications (e.g., "clinical chemist with X years of experience").
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of expert adjudication. The "adjudication" of the control's value is purely statistical: "The mean is used as setpoint." This means the results from the different independent series and laboratories are averaged to determine the final assigned value for the control. There's no human consensus or tie-breaking process described beyond the statistical aggregation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Precinorm CK-MB & Precipath CK-MB controls are laboratory reagents used to monitor the performance of analytical instruments, not for human interpretation of clinical cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. These are physical control materials, not an algorithm. Their "performance" is based on their biochemical properties and the accuracy/precision of their assigned values, which are verified through laboratory testing.
7. The Type of Ground Truth Used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for the test set (the control material itself) is its assigned value, established through a rigorous value assignment process involving multiple measurements across multiple laboratories and traceable to reference methods/calibrators. This is an analytical/statistical ground truth based on quantitative chemical measurement, not a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. These are quality control materials, not an AI or machine learning algorithm that requires a "training set." The materials are manufactured to a specification, and their assigned values are verified, not learned.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for a quality control material.
§ 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.