(29 days)
This CalCheck set is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers.
The ß-CrossLaps CalCheck 5 is used for the calibration verification and the assessment of the measuring range as needed by the laboratory certification agencies such as College of American Pathologists or CLIA certification. The CalChecks are a customer convenience product and not required to assess the performance.
The provided document describes the ß-CrossLaps CalCheck 5, a quality control material intended for calibration verification and assay range verification on cobas e immunoassay analyzers.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study/Parameter | Acceptance Criteria | Reported Device Performance (as per studies presented) |
|---|---|---|
| Value Assignment | Assigned range for Levels 2-5: ±27% of the assigned value. | |
| Target Value for Check 1: ≤0.05 ng/mL | The CalChecks are run in duplicate on at least two (2) modules (each with two measuring cells) of the cobas e 801 with at least two runs. The assigned value is the median of at least six (6) determinations. The acceptance criterion for the assigned range is applied. | |
| Open Vial Stability | CalCheck Level 1: |
§ 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.