(35 days)
The ADVIA Centaur® TnI-Ultra® Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur TnI-Ultra assay.
The ADVIA Centaur® Digoxin Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay.
ADVIA Centaur® TnI-Ultra® Master Curve Material is an in vitro diagnostic product containing various levels of bovine cardiac troponin I in a goat serum matrix with preservatives. Each set contains five lyophilized levels (MCM1-5); with a reconstituted volume of 1.0 ml each. MCM1 contains no analyte. The Tnl-Ultra MCMs assigned values are lot-specific of target values 0.00, 1.00, 3.50, 14.0 and 40.0 ng/mL.
ADVIA Centaur® Digoxin Master Curve Materials is an in vitro diagnostic product containing various levels of digoxin in defibrinated human plasma with sodium azide (0.1% after reconstitution) and preservatives. Each set contains six lyophilized levels (MCM1-6); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The Digoxin MCMs assigned values are lot specific of target values 0.0, 0.50, 1.00, 2.00, 3.00, 5.50 ng/mL.
The provided text describes two separate devices: ADVIA Centaur® TnI-Ultra® Master Curve Material (MCM) and ADVIA Centaur® Digoxin Master Curve Material (MCM). Both are quality control materials. I will detail the acceptance criteria and study information for each device independently.
ADVIA Centaur® TnI-Ultra® Master Curve Material (MCM)
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance (Supports Claims) |
|---|---|---|
| Stability: Real Time/Shelf Life (Unopened) | - MCM1: Dose recovery ≤ 0.02 dose |
- MCM2-5: % dose recovery within 85% to 115% calculated to Day 0
- No adverse trends | Acceptance criteria were met up to the 10 months time point, supporting a shelf-life claim of 9 months. |
| Stability: In Use (Open Vial) @ 2-8°C (Reconstituted) | - MCM1: Dose recovery ≤ 0.02 dose (versus freshly reconstituted -80°C stored MCM1 average dose) - MCM2-5: % dose recovery within 85% to 115% (versus freshly reconstituted -80°C stored MCM2-5 average dose) | Acceptance criteria were met up to the 9 hour time point, supporting an open vial claim of 8 hours when stored at 2-8°C. |
| Stability: In Use (Open Vial) @ -20°C (Reconstituted) | - MCM1: Dose recovery ≤ 0.02 dose (versus freshly reconstituted -80°C stored MCM1 average dose) - MCM2-5: % dose recovery within 85% to 115% (versus freshly reconstituted -80°C stored MCM2-5 average dose) | Acceptance criteria were met up to the 63 days time point, supporting an open vial (reconstituted) claim stored at -20°C for 60 days. |
| Stability: On-Board | - 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.