(27 days)
EURO/DPC's TMC is an assayed, human serum-based, tri-level control containing several human source-derived analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro diagnostic use as an aid in monitoring the day-to-day performance of assays for these constituents.
Quality Control Material
I am sorry, but the provided text does not contain information on acceptance criteria, device performance, clinical study details, or ground truth establishment. The document is a 510(k) summary for a "Tumor Marker Control Device," which is a quality control material, not a diagnostic device with performance metrics related to patient outcomes.
Therefore, I cannot populate the table or answer the questions related to clinical studies, human readers, or ground truth.
Here's what I can tell you based on the provided text:
- Device Name: Tumor Marker Control Device (Trade: TMC, Catalog Number: TMCO)
- Intended Use: "an aid in monitoring the day-to-day performance of assays for these constituents." (referring to analytes associated with malignancy)
- Clinical Studies: The document explicitly states "Not applicable" for clinical studies. This is expected for a quality control material, as its performance is evaluated against established assay values, not clinical outcomes.
Since there are no clinical studies or performance data against specific acceptance criteria for a diagnostic device, the requested information cannot be extracted from this document.
§ 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.