(28 days)
Liquichek Spinal Fluid Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Spinal Fluid Control is a human based control with added constituents of human origin and pure chemicals. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided text is a 510(k) summary for the Liquichek Spinal Fluid Control device. It describes the device, its intended use, and compares it to a substantially equivalent predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence to a previously cleared device (K932076) based on technological characteristics and intended use. Performance data, acceptance criteria, or a study to demonstrate performance against specific criteria are not included in this type of submission document.
Therefore, I cannot provide the requested information based on the input text.
§ 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.