(57 days)
The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a medical device. However, the provided document does not contain any information about acceptance criteria, study design, or device performance data.
The letter is a regulatory document affirming that the device, "Multi-Chem Calibrator A," is substantially equivalent to a predicate device and can be marketed. It lists the device name, regulation number, regulatory class, and product code, along with the device's intended use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided input. The information you are looking for (acceptance criteria, study details, sample sizes, ground truth, etc.) would typically be found in the 510(k) summary, test reports, or clinical study reports, which are not part of this document.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.