(25 days)
N CRP Standard SY is intended to be used for the establishment of reference curves.
The proposed calibrator, N CRP Standard SY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer 11 K943997) for the calibration of the N Latex CRP mono test.
Here's an analysis of the provided text regarding the N CRP Standard SY device, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric / Criterion | Reported Device Performance |
|---|---|---|
| Precision | %CV range | 1.43% to 4.47% |
| Stability (Lyophilized) | Duration | At least 12 months |
| Stability (Reconstituted) | Duration | 4 weeks |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Precision studies using one lot of N CRP Standard SY were run on the Behring Nephelometer." It does not specify a sample size for the test set (e.g., number of replicates, number of runs).
The data provenance is implied to be from internal testing by the manufacturer, Behring Diagnostics Inc. There is no information about the country of origin of the data beyond the manufacturing location (Germany) and distributor location (USA). The study is unequivocally prospective as it involves direct testing of the proposed device.
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 this device. This device is a calibrator, and its performance is assessed through its inherent analytical characteristics (precision, stability) rather than by comparison to a "ground truth" derived from expert interpretation of clinical data. There are no clinical images or patient outcomes being evaluated by experts here.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no expert interpretation or consensus-building involved in assessing the performance of this calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human interpretation (e.g., AI for radiology), not for a calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable in the context of this device. The device itself is a physical calibrator. Its performance is what is being evaluated directly through analytical studies. There isn't an "algorithm" in the sense of a standalone diagnostic tool.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating this calibrator is its inherent analytical characteristics tested against predefined specifications for precision and stability. It's not based on expert consensus, pathology, or outcomes data. The concentrations of CRP in the calibrator are established during its manufacturing and qualification process, and the tests verify that these characteristics remain within acceptable limits over time and across measurements.
8. The Sample Size for the Training Set:
This information is not applicable. This device is a calibrator, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.