(10 days)
This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT" Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values for the various analytical systems on which is was assayed. This material is not intended for use on those clinical chemistry systems employing reflectance spectroscopy.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a calibrator device, not a study report or clinical trial. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, or ground truth establishment.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not present data from a study demonstrating specific performance metrics against acceptance criteria.
§ 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.