(34 days)
Abbott Lyophilized Assayed Chemistry Control 3 is intended for use as a guality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
Not Found
This document is a 510(k) clearance letter from the FDA for the Abbott Lyophilized Assayed Chemistry Control 3. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory responsibilities and contacts for further information.
Therefore, I cannot provide the requested table and study details based on the provided text. The document is administrative in nature, confirming regulatory clearance rather than presenting technical performance data.
§ 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.