(138 days)
V8 SP Normal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.
V8 SP Abnormal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.
Not Found
I am sorry, but this document contains no information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Helena Laboratories for a device called "V8 SP Normal Control and V8 SP Abnormal Control". It primarily discusses the regulatory classification of the device and general compliance requirements, but does not include any performance data or study details.
Therefore, I cannot provide the requested information based on the provided 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.