(44 days)
PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
The PreciControl ClinChem Multi 1 and 2 are quality control products consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of the components in the controls have been adjusted to represent normal and pathological levels. The concentrations of the components in the controls are lot-specific and representative values are given in the enclosed value sheets.
Here's a breakdown of the acceptance criteria and study information for the PreciControl ClinChem Multi 1 and 2 device, based on the provided 510(k) summary:
This device is a quality control product, not a diagnostic device that interprets data for diagnosis. Therefore, many of the typical acceptance criteria and study aspects related to diagnostic accuracy (like sensitivity, specificity, or reader studies) are not applicable. Instead, the focus for this type of device is on demonstrating substantial equivalence to an existing legally marketed device, primarily by comparing their intended use, format, stability, traceability, value assignment, and constituent analytes.
Please note: The provided document is a 510(k) summary, which often summarizes the key information without all the granular details of the full submission. Therefore, some specific details might not be explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control (QC) product, "acceptance criteria" and "reported device performance" are typically framed around demonstrating equivalence to a predicate device in terms of its characteristics and how well it functions as a QC material.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (as compared to Predicate) |
|---|---|
| Intended Use: For use in quality control by monitoring accuracy and precision for quantitative methods. | Same as predicate: "PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets." |
| Format: Lyophilized human sera-based controls with adjusted concentrations/activities in normal and pathological ranges. | Same as predicate: "PreciControl ClinChem Multi 1 and 2 are lyophilized controls based on human serum. The adjusted concentrations and activities of the control components are in the normal and pathological ranges." |
| Stability: Acceptable stability profile (unopened, after reconstitution). | Same for unopened stability. Same for reconstituted stability with minor differences in listed exceptions for analytes. This is noted as "Same" in the table, with the predicate's details provided (e.g., "at 2-8 °C 5 days"). |
| Traceability: Traceability of target values to instructions for use of system reagents. | Same as predicate: "Traceability of the target values is given in the respective instructions for use of the system reagents." |
| Value Assignment: Traceable through Master Lot to standards or reference methods. | Same as predicate: "Traceable through Master Lot to standards or reference methods." |
| Constituent Analytes: Coverage of similar analytes as the predicate. | The device includes all analytes of the predicate ("Same" list provided). The device does not include some analytes found in the predicate (e.g., Acid phosphatase, Bicarbonate). The device includes additional analytes not in the predicate (e.g., Apolipoprotein A-1, C Reactive protein). The differences are detailed in the "Constituent Analytes" section. However, the core set of analytes is covered, and the differences are presented for review by the FDA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not explicitly provided in the 510(k) summary. For a quality control device focusing on substantial equivalence, the "test set" would typically refer to the samples used to characterize the new control's properties (e.g., stability studies, homogeneity studies, value assignment verification). The summary outlines the comparison to the predicate, implying that such studies were performed to generate the data for comparison, but the specific sample sizes for these internal studies are not detailed here.
- Data Provenance: This information is not explicitly provided. It is implied to be data generated by Roche Diagnostics, likely in a controlled laboratory setting relevant to their manufacturing and quality control processes. It is generally prospective data generated specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: This concept (experts establishing ground truth for a test set) is not applicable in the same way it would be for a diagnostic AI device. For quality control materials, "ground truth" is established through highly standardized and traceable analytical methods, often involving certified reference materials, reference methods (e.g., NIST standards), and rigorous laboratory procedures for value assignment by the manufacturer, rather than expert interpretation of images or clinical cases.
- Qualifications of Experts: Not applicable in this context. The "experts" would be the chemists, clinical scientists, and metrology specialists involved in the development and validation of the control materials and their value assignment, rather than medical specialists.
4. Adjudication Method for the Test Set
- Adjudication Method: This concept is not applicable. Adjudication (e.g., 2+1, 3+1) is typically used in reader studies for diagnostic devices where subjective human interpretation is involved. For a quality control product, performance is determined by objective analytical measurements and comparisons to established reference values or predicate device performance.
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 to diagnostic interpretation by human readers, often with or without AI assistance, to assess the impact of AI on human accuracy. This device is a quality control material and does not involve human interpretation or AI assistance in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an "algorithm only" device. This device is a chemical control material used to monitor the performance of other analytical instruments. Its "performance" is its ability to consistently produce specific analyte values and behave predictably as a control, aligning with its assigned values and stability claims, and demonstrating equivalence to its predicate.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this quality control device, the "ground truth" for the analyte concentrations in the control material would be established through traceability to internationally recognized reference materials and/or established reference methods. The summary explicitly states: "Traceable through Master Lot to standards or reference methods." This implies a metrological approach where the assigned values are linked to a higher-order accuracy standard.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This concept is not applicable. This device is a physical chemical control product, not an AI/machine learning algorithm that requires a training set. The development of such a product involves formulation, manufacturing, and extensive analytical testing to characterize its properties, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: This concept is not applicable as there is no "training set" for this type of device. The "ground truth" (assigned values) for the control material itself is established through a rigorous value assignment process, which includes testing multiple lots, using various analytical systems, and reference to primary standards or reference methods.
§ 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.