(32 days)
Cardiolmmune®XL Cardiac Marker Control is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Not Found
This is a 510(k) premarket notification for a cardiac marker control device, not an AI or medical imaging device. Therefore, the questions about acceptance criteria, study design, ground truth, experts, and sample sizes that are typically relevant for AI/imaging devices are not applicable here.
The document states:
- Device Name: CardioImmune® XL Cardiac Marker Control
- Regulation Number: 21 CFR § 862.1660
- Regulation Name: Quality control material (assayed and unassayed)
- Regulatory Class: Class I
- Product Code: JJY
- Indications For Use: "CardioImmune®XL Cardiac Marker Control is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations."
For a Class I quality control material, the "acceptance criteria" generally refer to the performance specifications of the control material itself (e.g., target values, acceptable ranges, stability) and its ability to monitor the performance of assays. The "study" would typically involve demonstrating that the control material provides consistent and reliable results within its defined ranges and is stable over time, as well as showing substantial equivalence to existing predicate devices.
However, the provided text does not contain the specific performance data, study results, or detailed acceptance criteria for this particular device. It is a regulatory clearance letter rather than a performance study report.
Therefore, I cannot populate the table or answer the specific questions as they pertain to aspects that are either not present in this document or are not relevant to this type of device and regulatory submission.
§ 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.