(86 days)
RaPET CRP (Class II) is intended for the qualitative and the semi-quantitative detection of C-Reactive Protein (CRP) in human serum. The latex slide test is intended to be used as an aid in evaluation of the amount of injury to body tissues.
The device test kit is comprised of CRP Latex Reagent, CRP Positive Control, Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.
The provided K974429 510(k) summary for RaPET® CRP includes information on the device's intended use and performance data. However, it does not explicitly define acceptance criteria as a separate table nor does it detail a study proving the device meets specific numerical acceptance criteria in the way a modern regulatory submission might. Instead, it demonstrates substantial equivalency to a predicate device.
Here's an attempt to structure the information based on your request, inferring what "acceptance criteria" might mean in the context of this 1998 submission, and highlighting where information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Inferred/Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison (Correlation to Predicate) | Strong correlation (implicit) | Correlation coefficient: 0.964, Regression equation: Y=0.93X + 0.36 (compared to Pulse's C-Reactive Protein Test) |
| Precision | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
| Sensitivity | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
| Specificity | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
| Interference Studies | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the studies (method comparison, precision, sensitivity, specificity, interference).
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. Given the nature of a CRP latex agglutination test, ground truth would likely be established through quantitative laboratory methods, not expert visual assessment.
4. Adjudication method for the test set
- This information is not applicable/not provided. The assessment appears to be based on direct comparison to a predicate device and classical analytical performance studies, not opinion-based 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
- This information is not applicable/not provided. The RaPET® CRP is a laboratory assay kit, not an AI-assisted diagnostic imaging or human assessment tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable/not provided. This is a manual latex agglutination test, not an algorithm. The "performance data" refers to the analytical performance of the kit itself.
7. The type of ground truth used
- The primary "ground truth" or reference method for the method comparison was a predicate device (Pulse's C-Reactive Protein Test).
- For precision, sensitivity, specificity, and interference studies, the ground truth would typically be established by controlled laboratory experiments and/or quantitative reference methods, but the specific details are not provided.
8. The sample size for the training set
- This information is not applicable/not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable/not provided, as there is no training set for this type of device.
§ 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).