(44 days)
Lyphochek Whole Blood Metals 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.
Lyphochek Whole Blood Metals Control is prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.
The provided document describes a medical device, the Lyphochek Whole Blood Metals Control, and its 510(k) submission for substantial equivalence. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of device performance metrics like accuracy, sensitivity, or specificity. Instead, the document focuses on regulatory approval based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, or study methodologies because this document does not contain that type of data.
The relevant information from the document is related to the regulatory comparison:
- Device Name: Lyphochek Whole Blood Metals Control
- Intended Use: An assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
- Predicate Device: Lyphochek Whole Blood Control (K980871)
- Basis for Approval: Substantial equivalence to the predicate device.
The tables in the document compare the technological characteristics of the new device with the predicate device, showing their similarities, rather than presenting a performance study against predefined acceptance criteria.
§ 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.