(19 days)
Lyphochek Hypertension Markers Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Hypertension Markers Control is prepared from defibrinated human plasma with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability. This product contains 0.1% sodium azide as a preservative.
The provided document is a 510(k) summary for the Lyphochek Hypertension Markers Control device. This device is classified as a Class I Quality Control Material (Assayed and Unassayed) and is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes.
However, the 510(k) summary does not contain a study that proves the device meets specific acceptance criteria in terms of performance measures like sensitivity, specificity, accuracy, etc., for diagnostic purposes. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Ciba Corning Diagnostics Renin Control) based on shared technological characteristics and intended use as a quality control material.
The document highlights the device's characteristics and compares them to the predicate device to justify its marketing. Key information regarding performance studies and acceptance criteria as outlined in your request is not present for this type of device submission. Quality control materials are generally assessed for their stability, homogeneity, and assigned values, rather than through clinical performance studies against a "ground truth" in the same way a diagnostic device would be.
Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance table, sample sizes for test/training sets, expert qualifications, or details about MRMC studies because this information is not part of this 510(k) submission for a quality control material.
The 510(k) summary focuses on the following:
- Intended Use: To monitor the precision of laboratory testing procedures for specified analytes.
- Technological Characteristics: Comparison to a predicate device regarding intended use, levels, form, open vial claim, matrix, and storage.
The closest information to "acceptance criteria" for a quality control material would be related to its manufacturing specifications, stability, and the accuracy of its assigned analyte values, none of which are detailed as performance "acceptance criteria" with study results in this 510(k) summary.
§ 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.