(44 days)
Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Total Protein, and Urea on the Olympus™ series of chemistry analyzers.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Olympus™ Urine Calibrator, a Class II device. It primarily focuses on the device's substantial equivalence to a predicate device and its intended use for calibrating various urine chemistry assays on Olympus™ chemistry analyzers.
However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, or expert involvement. These types of details are typically found in the more comprehensive 510(k) submission itself, not in the FDA's decision letter.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study, as this information is not present in the provided text.
§ 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.