(38 days)
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay systems within the clinical range.
The provided text describes the 510(k) summary for Good Biotech Corp.'s CRPex CRP Controls, intended for use as an assayed quality control material for serum C-reactive protein (CRP) analysis. It focuses on demonstrating substantial equivalence to a predicate device, Roche CRP T Control N.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this context are primarily demonstrating substantial equivalence to a predicate device by showing comparable characteristics. The "performance" is implicitly the C-reactive protein concentration range.
| Acceptance Criteria | Reported Device Performance (CRPex CRP Controls) | Predicate Device (Roche CRP T Control N) |
|---|---|---|
| Matrix/Biological Sources: Must be comparable to predicate. | Liquid human serum | Liquid human serum |
| Concentration Range (mg/L): Must provide appropriate control levels for CRP analysis. | Level L: 1.28 – 1.92 | |
| Level M: 4.54 – 6.81 | ||
| Level H: 46.82 – 70.23 | Level M: 3.44 – 4.66 | |
| (Specific ranges for L and H levels of the predicate are not explicitly stated, but the overall purpose is to show comparable function and suitable ranges for quality control) |
Note: While the exact "acceptance criteria" for the concentration ranges aren't explicitly stated as numerical targets that were met, the submission implies that these ranges are deemed acceptable for the intended use and demonstrate equivalence to the predicate control.
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not provide information on sample sizes used for a test set or data provenance for performance studies. As a quality control material, the "study" typically involves determining the assigned values and stability of the control, rather than a diagnostic performance study on patient samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a quality control material, "ground truth" would typically refer to the accurately assigned values of CRP within the control, established through rigorous analytical methods and reference materials, rather than expert consensus on diagnostic images or clinical data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which are not applicable to the evaluation of a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This document does not mention an MRMC comparative effectiveness study. MRMC studies are typically conducted for diagnostic devices (e.g., imaging AI) where human readers interpret cases with and without AI assistance. This is not applicable to a CRP control material.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable to the given device. The CRPex CRP Controls are a material used to assess the performance of other assay systems, not a standalone diagnostic algorithm. The "performance" of the controls themselves relates to their stability, homogeneity, and accurately assigned values, which are evaluated through analytical methods.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" refers to the assigned C-reactive protein concentrations within the various control levels (L, M, H). This would be established through:
- Quantitative analytical methods: Using a reference method or a highly accurate clinical analyzer calibrated against certified reference materials.
- Traceability to international standards: Ensuring the assigned values are traceable to recognized CRP standards.
The document states that the controls have "assigned C-reactive protein concentration," indicating this type of ground truth was established.
8. Sample Size for the Training Set
This information is not provided. As a quality control material, there isn't a "training set" in the context of machine learning or AI. The development of the control involves formulation, testing for stability, homogeneity, and value assignment, not training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this device. The ground truth (assigned CRP concentrations) for the control material itself would be established through analytical testing and value assignment protocols, as described in point 7.
§ 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.