(89 days)
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples.
The provided text describes the Beckman IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the method comparison in a clear quantitative manner (e.g., a specific R-value threshold). However, it implies that the device is substantially equivalent to the predicate through the presented performance data.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (IMMAGE CRP Reagent) |
|---|---|---|
| Method Comparison | Substantial equivalence to Behring N Latex CRP Reagent. | Demonstrated through method comparison study (details not fully provided in text). |
| Stability (Shelf-life) | Not explicitly stated (typically defined internally by manufacturer). | 24 month shelf-life |
| Stability (Open Container) | Not explicitly stated. | 14 days |
| Stability (Calibration) | Not explicitly stated. | 14 days |
| Within-run Imprecision | Not explicitly stated (typically defined by industry standards or manufacturer's target). | Level 1 (Mean 1.65 mg/dL): %CV = 8.1% |
| Level 2 (Mean 5.41 mg/dL): %CV = 3.1% | ||
| Level 3 (Mean 12.6 mg/dL): %CV = 1.8% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample size for the method comparison study (comparison between IMMAGE CRP Reagent and Behring N Latex CRP Reagent).
- 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 Qualifications of those Experts
- This information is not applicable to an immunochemistry reagent like the one described. "Ground truth" for such a device is established by comparing its quantitative results against a recognized reference method or a legally marketed predicate device, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
- Not applicable as this is a quantitative chemical assay, not a diagnostic imaging or interpretive device requiring 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
- Not applicable. This device is an in-vitro diagnostic (IVD) reagent for automated quantitative measurement, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance data presented (method comparison, stability, imprecision) represents the standalone performance of the IMMAGE CRP Reagent system. The device itself performs the quantitative measurement without human interpretation of the results for its basic function.
7. The Type of Ground Truth Used
- For the method comparison study, the "ground truth" was established by the results obtained from the predicate device (Behring N Latex CRP Reagent). The study aimed to demonstrate substantial equivalence to this legally marketed device.
- For the stability and imprecision studies, the "ground truth" is typically derived from known control materials or calibrated reference solutions with assigned values.
8. The Sample Size for the Training Set
- This information is not applicable as this is not a machine learning or AI device that requires a distinct "training set" in the context of the reported performance studies. The "training" of such a system involves internal development and optimization based on chemical and analytical principles.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the reasons stated in point 8.
§ 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).