(15 days)
Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
The document describes the device, Liquichek™ Cardiac Markers Control LT, as an assayed quality control serum. The "acceptance criteria" in this context refers to the stability of the analytes within the control serum under specified storage conditions, which determines its shelf life and open-vial stability. The study conducted to "prove the device meets the acceptance criteria" is a series of stability studies.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance |
|---|---|
| Open Vial Stability (2-8°C, tightly capped) | |
| - Troponin-I, Troponin T, and Homocysteine stability | 10 days |
| - Myoglobin, CK-MB, and Digitoxin stability | 20 days |
| Shelf Life (Unopened, -20°C or colder) | 2 years |
| Preservatives | Contains a broad-spectrum anti-microbial cocktail ( |
§ 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.