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The MAS® Cardiolmmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include Cardiolmmune® proBNP with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

MAS® CardioImmune® proBNP Liquid Assayed Cardiac Marker Control Level 1, 2 and 3

The provided document is a 510(k) premarket notification letter from the FDA regarding the MAS® CardioImmune® proBNP. This letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Regulatory classification: Class I product, regulation number 21 CFR 862.1660 (Quality Control Material, Assayed and Unassayed).
• Substantial equivalence: The device is deemed substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• General controls: Listing the requirements of the Federal Food, Drug, and Cosmetic Act (Act) that the manufacturer must comply with (e.g., registration, listing, labeling, good manufacturing practices).
• Indications for Use: The device is an assayed control serum for monitoring assay conditions in cardiac marker determinations in clinical laboratories.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document is a regulatory clearance letter, not a performance study report.

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