(21 days)
Clinical laboratories performing chemistry assays may use huve mentioned controls routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls (Levels 1 and 2) are used as an adjunct to primary control procedure recommended by the manufacturer of reagents and instrument used for the measurement; (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory quality control goals; (c ) above mentioned controls are validated for use with the specific clinical chemistry test system used by the laboratory.
QUIKCHECK Unassayed Chemistry Control Levels 1 and 2
This document is a 510(k) premarket notification response from the FDA for a chemistry control device. It does not contain information about studies proving the device meets acceptance criteria as this is typically found in a Premarket Approval (PMA) application or a more detailed 510(k) submission document. The provided text is a notification that the device has been found substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.
§ 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.