(28 days)
The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur C-peptide assay.
The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Insulin assay.
ADVIA Centaur® C-peptide Master Curve Material is an in vitro diagnostic product containing various levels of C-peptide spiked in citric acid buffer with casein and preservatives. Each set contains ten levels (MCM1–10); ready-to-use 1.0 mL per level. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values 0.0 0.14, 0.25, 0.55, 1.05, 2.05, 4.00, 8.00, 16.0, 32.5 ng/mL.
ADVIA Centaur® Insulin Master Curve Materials is an in vitro diagnostic product containing various levels of insulin in buffered saline with casein, potassium thiocyanate (3.89%), sodium azide (
The provided document describes the Siemens ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM) and ADVIA Centaur Insulin (IRI) Master Curve Material (MCM). These devices are described as in vitro diagnostic products for the verification of calibration and reportable range of their respective assays. The document focuses on establishing substantial equivalence to predicate devices and describes relevant performance characteristics, primarily stability and value assignment.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Device Type: In vitro diagnostic Master Curve Material (MCM) - these are control materials used to verify the calibration and reportable range of an assay, not a diagnostic device that produces patient-specific results. Therefore, the questions related to clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, PPV, NPV), multi-reader multi-case studies, human reader improvement with AI, and specific ground truth types like pathology or outcomes data are not applicable in the context of this device and the provided documentation. The "performance" here refers to the stability and accurate value assignment of the control material itself.
1. Acceptance Criteria and Reported Device Performance
For ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM):
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Real Time/Shelf Life (Unopened) 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.