(77 days)
For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.
This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives.
The provided text is a 510(k) summary for a medical device called "SysCon (or other brand names) Tumor Marker Control." This document focuses on the regulatory submission for a quality control material and does not describe a study involving patient data, AI, or diagnostic algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truthing for such a device is not present in the provided text.
Based on the information given, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance data" related to the quality control material itself, not a diagnostic device's ability to interpret patient data.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary Statement) |
|---|---|
| Comparison to predicate device | "Comparison of the product to the predicate device for intended use, analytes, number of levels, form, diluent, base, additives, microbial content, lot homogeneity and vial-to-vial consistency, stability and reliability of assay values supports a substantial equivalence finding." |
| Nonclinical tests | "Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary." |
*Note: Specific numerical acceptance criteria (e.g., CV
§ 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.