(21 days)
Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively.
In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively.
N/T Rheumatology Controls SL (bi-level control; N/T Rheumatology Control SL/1 and N/T Rheumatology Control SL/2) is a multi-constituent control intended for use as a quality control material to monitor the accuracy of selected rheumatic and inflammatory disease with the Behring Nephelometer (BN), Behring Nephelometer 100 (BN-100) and the Behring TurbiTimeSystem® (TTS).
This is a quality control device for laboratory tests, not a device that involves human physiological measurements or AI. Therefore, most of the requested information (e.g., expert-established ground truth, MRMC studies, effect size of human improvement with AI, sample size for training sets) is not applicable to this type of device.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes performance characteristics related to accuracy. While explicit "acceptance criteria" for the device are not stated as numerical thresholds (e.g., "recovery must be between X% and Y%"), the study demonstrates that the device met the intended accuracy by showing a range of recovery within a generally acceptable range for quality control materials.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy as measured by percent recovery from assigned values. | Percent recoveries compared to assigned values ranged from 92.1% to 107.2%. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Multiple vials of the controls" were used. "Two lots of each control were tested." "Three lots of N Latex CRP mono reagent were assayed in replicates of five."
- Data Provenance: Not specified, but generally, quality control materials are tested in laboratory settings. This would be considered a prospective lab study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For a quality control material, the "ground truth" (assigned values) is typically established by the manufacturer through rigorous calibration and assay development against reference standards, not by clinical experts for diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are used when there is subjective interpretation of data (e.g., medical images). Here, the comparison is to pre-established assigned values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, often with and without AI assistance. This device is a quality control material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a quality control material, not an algorithm or AI system. Its performance is evaluated by its ability to accurately reflect known concentrations when used in conjunction with a diagnostic test.
7. The Type of Ground Truth Used
The "ground truth" for this device is the assigned values for the constituents in the control material. These values are established by the manufacturer using reference methods and standards during the product development and manufacturing process.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).