(102 days)
The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex (II)X2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples.
The CRP(II) Calibrator is intended to be used for the calibration of the CRP-Latex(II)X2 SEIKEN
The provided text describes a 510(k) submission for the "CRP(II) Calibrators" device. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.).
The document primarily focuses on the regulatory submission process and states that the calibrators are intended for use with the CRP-Latex(II)X2 SEIKEN assay kit. It mentions "Performance data" but then immediately states: "The CRP-Latex (II) "Seiken"X2 High Sensitivity Assay and the predicate device, N High Sensitivity CRP Assay have only minor difference that do not affect the performance, safety or effectiveness of the measurement." This implies that a detailed study demonstrating the calibrator's performance against specific acceptance criteria, as one would typically expect for a device, is not explicitly provided in this summary. Instead, it relies on substantial equivalence to a predicate device for the assay performance.
Therefore, for most of the requested points, the information is not available in the provided text.
Here's an attempt to answer based on the limited information given:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Intended Use: Calibration of the CRP-Latex(II)X2 SEIKEN assay for quantitating CRP in human serum and EDTA or lithium heparinized plasma samples. | The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex (II)X2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples. (This is an intended use statement, not a performance metric for the calibrator itself) |
| Assay Performance (as calibrated by the device): (Inferred from the statement about the assay it calibrates) | Lower level of detection (sensitivity of the assay): 0.05 mg/L Assay range: up to 10.0 mg/L (This refers to the assay performance, which the calibrator supports, rather than the calibrator's direct performance. The document states the calibrator is for this assay.) The document also states: "The CRP-Latex (II) "Seiken"X2 High Sensitivity Assay and the predicate device, N High Sensitivity CRP Assay have only minor difference that do not affect the performance, safety or effectiveness of the measurement." |
2. Sample size used for the test set and the data provenance:
- Not available. The document does not describe a specific test set for the calibrator's performance. It relies on the substantial equivalence of the CRP-Latex(II)X2 SEIKEN High Sensitivity Assay to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. There is no mention of a test set requiring expert ground truth establishment for the calibrator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available.
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 a calibrator for a laboratory assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a calibrator, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not available. Since no specific study details are provided for the calibrators, the type of ground truth for performance assessment is not mentioned. For the assay itself, typically, established reference methods or primary standards would serve as ground truth for accuracy and precision studies, but such studies are not detailed here for the calibrator.
8. The sample size for the training set:
- Not available. The document does not describe a training set for the calibrator.
9. How the ground truth for the training set was established:
- Not available.
§ 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.