(11 days)
CLINIQA LiniCAL™ Uric Acid Calibration Verifiers Levels A – E for Olympus AU Systems™ CLINIQA LiniCAL - Ont Atla Control products which may be used to evaluations are "assayed," liquid," quality" ontrol production with in the useful concentrations.
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This is a letter, not a study report. It states that the FDA reviewed a 510(k) premarket notification for the "LiniCAL™ Uric Acid Calibration Verifiers Levels A-E for Olympus AU Systems" and determined the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study. The letter is an FDA clearance, not a 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.