Search Results

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.

Ask a specific question about this device