(48 days)
The Elecsys T4 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's a breakdown of the acceptance criteria and study information for the Elecsys T4 CalCheck 5, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device (Elecsys T3 CalCheck 5) rather than explicitly stating specific numerical acceptance criteria for the Elecsys T4 CalCheck 5. However, the performance characteristics section mentions "value assignment and stability" as evaluation points. From the comparison table with the predicate, we can infer some targets or expected ranges for "Check Target Values" and "Assay Measuring Range".
| Characteristic | Acceptance Criteria (Inferred from Predicate/Device Spec.) | Reported Device Performance (Assumed to meet, since cleared) |
|---|---|---|
| Intended Use | Assayed control for calibration verification and assay range verification for Elecsys T4 reagent on Elecsys and cobas e immunoassay analyzers. | Meets the stated intended use. |
| Analyte | Thyroxine (T4) | Contains Thyroxine (T4). |
| Number of Levels | Five | Five levels provided. |
| Assay Measuring Range | 5.40 - 320 nmol/L | The device is designed to verify this range. |
| Check Target Values | Check 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.