(54 days)
CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 are intended for use as an assayed quality control material. It is not intended for use as a standard. Assay values for analytes listed in this product insert are provided for both levels.
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I am sorry but this document does not contain the information you are looking for. This is a 510(k) premarket notification letter from the FDA to Cliniqa Corporation regarding their Liquid QC Urine Chemistry Controls. It confirms the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth information.
§ 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.