(24 days)
The OPUS Myoglobin Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS Mvoqlobin assay.
The OPUS Myoglobin Controls are lyophilized controls containing known levels of human myoglobin in processed human serum. The control is provided at three levels (low, mid and high). The OPUS Myoglobin Control is only for use with the OPUS Myoglobin assay and has not been evaluated for use with other assays.
The provided text describes a 510(k) summary for "OPUS Myoglobin Controls," which are quality control materials. It does not describe a study involving a diagnostic device that detects or diagnoses a condition, nor does it present acceptance criteria and performance data in the typical sense of a diagnostic accuracy study.
Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission for quality control materials.
However, I can extract the closest analogous information regarding "acceptance criteria" (implied performance expectations for a QC material) and "device performance" (results of the precision study).
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intra-assay Precision: Not explicitly stated, but generally, acceptable CVs for QC materials in immunoassays are typically low (e.g., |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.