(62 days)
Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions. It is intended to simulate human patient plasma samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays.
Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions.
This document is a 510(k) premarket notification decision letter from the FDA for a quality control material, not a medical device that requires a study to prove its performance against acceptance criteria in the typical sense of diagnostic or therapeutic devices. Therefore, a table of acceptance criteria and device performance, and details about studies with ground truth, experts, sample sizes, and adjudication methods are not applicable here.
This document pertains to the Audit™ MicroControl MicroFDTM BNP Control, which is a quality control material. Its purpose is to monitor the precision and detect systematic analytical deviations of laboratory testing procedures for BNP-32 and NT-proBNP assays.
The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a premarket approval application (PMA). This determination is based on the device meeting the requirements for general controls provisions of the Act, which include annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Therefore, the request for acceptance criteria and study details cannot be fulfilled from the provided document. The document does not describe performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device, nor does it detail a clinical study with an aim to prove such performance. Instead, it confirms the regulatory clearance of a quality control product.
§ 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.