(30 days)
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.
§ 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.