(35 days)
Assayed EasyLyte Quality Control Kit is intended for use with IV trolyte and yers to estimate test imprecision and to detects variation. eagent
EasyLyte Quality Control Kit
This document is a 510(k) clearance letter from the FDA for a medical device called the "EasyLyte Quality Control Kit." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a performance study for an AI/ML medical device would.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device's clearance is based on its substantial equivalence to existing, legally marketed predicate devices, not on a new study demonstrating its performance against specific acceptance criteria for a novel technology or AI algorithm.
Therefore, I cannot provide the requested information because it is not contained within the provided text. The document is a regulatory approval notice, not a clinical or 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.