(17 days)
Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.
Liquichek Homocysteine Control is prepared from human serum with added Liquichek Homocystellie Control is propared from hands been is provided in liquid form for convenience. This product contains
The provided text lacks information regarding acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Liquichek Homocysteine Control), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria and study results.
Therefore, I cannot provide the requested 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.