(34 days)
The ADVIA Centaur® IgE Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Total IgE assay.
ADVIA Centaur® IgE Master Curve Material is an in vitro diagnostic product containing various levels of IgE spiked in lyophilized human plasma with sodium azide (0.1%) and preservatives. Each set contains seven levels (MCM1–7); with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.0, 12.5, 40.0, 270, 1000, 1700, and 3150 IU/mL.
This document describes the ADVIA Centaur® IgE Master Curve Material (MCM), a quality control material used for in vitro diagnostic verification of calibration and reportable range of the ADVIA Centaur Total IgE assay. It is not an AI/ML device, and therefore several of the requested sections (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, data provenance) are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a quality control material, not a diagnostic test with metrics like sensitivity or specificity. Its performance is measured by its stability and its ability to be correctly value-assigned.
| Performance Metric | Acceptance Criteria (Sponsor's Required Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Real Time/Shelf Life Stability | MCM1 dose recovery ≤ 2.0 IU/mL; MCM2-7 % dose recovery met sponsor's required acceptance criteria. | Current testing meets the sponsor's acceptance criteria for the real-time stability study up to the 9 months' time point, supporting an 8-month shelf-life claim when stored unopened at 2-8°C. |
| In-Use Open Vial (Reconstituted) Stability | MCM1 dose recovery |
§ 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.