(64 days)
Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems.
Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems.
Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided 510(k) summary for the "Roche® CRP T Control N" device, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study for a diagnostic device.
This device is a control product, meaning its purpose is to monitor the accuracy and precision of quantitative C-reactive protein (CRP) assays. It is not a diagnostic device itself that directly measures a patient's CRP level or diagnoses a condition. Therefore, the "study" and "acceptance criteria" for such a product are typically focused on its manufacturing specifications, stability, and its ability to consistently produce expected values within a defined range when run on an assay.
The 510(k) process for control products often relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive new clinical performance studies.
Here's how the requested information maps to the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Expected Value Range) | Reported Device Performance (Mean | Standard Deviation) |
|---|---|---|
| 3.44 - 4.66 mg/L (Concentration Range for Roche CRP T Control N) | Not explicitly stated as "reported device performance" in the context of meeting acceptance criteria, but this is the defined range for the control. | |
| Comments: The document does not present a table of specific acceptance criteria met by a study. Instead, it provides the concentration range for the Roche CRP T Control N (3.44 - 4.66 mg/L), which serves as its defining characteristic and what it's expected to deliver when used. The comparison to the predicate device also lists concentration ranges. The concept of "acceptance criteria" for this device revolves around its ability to consistently fall within this specified range when tested, ensuring it functions as a reliable control. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not provided. The document explicitly states: "No clinical or nonclinical tests were performed for this product."
- Data Provenance: Not applicable, as no tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable / Not provided. Since no clinical or nonclinical tests were performed, there was no "test set" requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / Not provided. No test set was used that would require adjudication.
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. This is a control product for a C-reactive protein assay, not an AI-assisted diagnostic device. The concept of "human readers" and "AI assistance" is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable / Not provided. No clinical or nonclinical tests were performed requiring a ground truth determination. For control products, the "ground truth" often refers to the highly accurate and validated "assigned values" or "target ranges" established during manufacturing and characterized by reference methods. While the document provides a "Concentration Range," it doesn't detail how this range was established with respect to a "ground truth" source in a study context.
8. The sample size for the training set
- Training Set Sample Size: Not applicable / Not provided. This is not a machine learning or algorithm-based device that would require a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable / Not provided. No training set was used.
Summary of Approach in the Document:
The document primarily relies on substantial equivalence to a previously cleared predicate device ("Behring Diagnostics N/T Rheumatology Control SL 1 / 2"). The key comparison points are:
- Matrix/Biological Sources: Both are "Liquid human serum."
- Concentration Range: Roche CRP T Control N has a range of 3.44 - 4.66 mg/L, which is compared to the two levels of the predicate (Level 1: 9.0 - 12.2 mg/L and Level 2: 40.3 - 54.5 mg/L). While the ranges are different, this is acceptable for controls as long as they are manufactured to specific, consistent target values. The critical aspect is that they are both human serum-based controls for CRP assays.
The statement "No clinical or nonclinical tests were performed for this product" signifies that Roche is asserting that the device's function as a control product is sufficiently demonstrated by its similarity to the predicate and its manufacturing specifications, without the need for additional performance studies as typically required for primary diagnostic devices. The FDA's clearance letter confirms their acceptance of this approach for substantial equivalence.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).