(57 days)
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays using the Elecsys immunoassay systems (Elecsys 2010, 1010 and others of the Elecsys family of instruments).
PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
This 510(k) submission is for a quality control material (PreciControl Tumor Marker), not a diagnostic device that directly assesses patient conditions. Therefore, many of the typical acceptance criteria and study components related to diagnostic accuracy (like sensitivity, specificity, reader studies, etc.) are not applicable in the usual sense.
The submission focuses on demonstrating substantial equivalence to a predicate quality control material, primarily by showing it performs its intended function (monitoring accuracy and precision of immunoassays) comparably. The "performance" here relates to its ability to serve as a reliable control, not to diagnose a disease.
Based on the provided text, here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or present a table of reported device performance in the way a diagnostic device submission might. Instead, it claims substantial equivalence based on the intended use and nature of the device.
The "performance" implied for a quality control material is its ability to:
- Contain lyophilized control serum with concentrations in two clinically relevant ranges.
- Be used for monitoring the accuracy and precision of Elecsys immunoassays.
The device meets these general performance characteristics as described.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of patient data. For a quality control material, testing would involve internal studies to characterize its stability, homogeneity, and assigned values. This information is not detailed in the provided K972235 summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a quality control material, not a diagnostic device requiring expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" would relate to the assigned values for the analytes within the control. These values are typically established through rigorous manufacturing processes, reference methods, and inter-laboratory studies. The document does not provide details on how these specific values were assigned for PreciControl Tumor Marker.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses a training set of data.
9. How the ground truth for the training set was established
Not applicable.
§ 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.