(28 days)
The ADVIA Centaur® Progesterone (PRGE) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Progesterone assay.
The ADVIA Centaur® Ferritin (FER) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Ferritin assay.
ADVIA Centaur® Progesterone Master Curve Material is an in vitro diagnostic product containing various levels of progesterone spiked in lyophilized human plasma with sodium azide (0.1%) and preservatives. Each set contains nine levels (MCM1-9); with a reconstituted volume of 1.0 mL/vial per level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 1.20, 2.50, 5.00, 10.0, 20.0, 30.0, 42.0, and 65.0 ng/mL.
ADVIA Centaur® Ferritin Master Curve Material is an in vitro diagnostic product containing various levels of ferritin in human serum with sodium azide. Each set contains eight levels; ready to use (MCM1-8); with a volume of 1.0 mL/vial per level. MCM1 contains no analyte. The FER MCMs assigned values are lot-specific of target values: 0.00, 5.00, 10.5, 47.0, 150, 470, 800, and 1750 ng/mL.
This document describes the acceptance criteria and supporting studies for two devices: the ADVIA Centaur® Progesterone (PRGE) Master Curve Material (MCM) and the ADVIA Centaur® Ferritin (FER) Master Curve Material (MCM). Both are quality control materials intended for in vitro diagnostic use in verifying the calibration and reportable range of their respective assays on ADVIA Centaur systems.
ADVIA Centaur® Progesterone (PRGE) Master Curve Material
1. Table of Acceptance Criteria and Reported Device Performance (Stability Studies)
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Real Time/Shelf Life (Unopened) | Dose recovery for MCM1 ≤ 0.15 ng/mL; For MCM2-9, % dose recovery met sponsor's required criteria. | Current testing met the sponsor's acceptance criteria up to the 7 months' time point, supporting a shelf-life claim of 6 months (stored at 2-8°C). |
| In-Use Open Vial (Reconstituted) | Dose recovery for MCM1 ≤ 0.15 ng/mL; For MCM2-9, % dose recovery met sponsor's required criteria. | Sponsor's acceptance criteria for the open vial (reconstituted) stability study were met to the 15 days' time point, supporting an open vial claim of 14 days when properly stored at 2-8°C. |
| On-Board Stability | Dose recovery for MCM1 ≤ 0.15 ng/mL; For MCM2-9, % dose recovery met sponsor's required criteria. | Sponsor's acceptance criteria for the on-board stability study were met up to 5 hours, supporting an on-board stability claim for 4 hours. |
| Value Assignment | New MCM doses must fall within the final value assignment specification for PRGE MCMs. Mean MCM doses of the new MCM lot must fall within customer range specifications. | Value assignment testing was conducted per the sponsor's procedure on the ADVIA Centaur XP system and met the pre-defined sponsor's acceptance criteria. MCM1 (analyte-free) measures at or below the PRGE assay sensitivity limit. MCM9 (diluted with MCM1) meets the reportable range. (Quantitative results not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Real Time/Shelf Life (Unopened): Test PRGE MCMs were stored unopened. Time points: T=0, 7 months, 10 months.
- In-Use Open Vial (Reconstituted): Pooled aliquots of reconstituted PRGE MCMs, 5 replicates per level. Time points: T=0, 2, 4, 7, 11, 14, and 15 days.
- On-Board Stability: Pooled aliquots of test PRGE MCMs in sample cups. Time points: T=0, 2, 4, and 5 hours.
- Value Assignment: Performance verification run consisting of 6 replicates of each MCM level.
- Data Provenance: Not explicitly stated, but assumed to be prospective internal Siemens Healthcare Diagnostics Inc. study data, likely from a lab in the USA (given the applicant's address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a quality control material which uses analytical comparisons against reference materials and manufacturer-defined specifications, not expert interpretation of results.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a quality control material, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study (Algorithm Only)
The device itself is a material, not an algorithm. The performance studies evaluate the stability and value assignment of the material based on the analytical results generated by the ADVIA Centaur XP system. These studies can be considered standalone evaluations of the material's properties.
7. Type of Ground Truth Used
- Stability Studies: Comparison of dose recoveries to -80°C reference MCMs (for unopened stability) or T=0 dose recovery results (for on-board stability).
- Value Assignment: Traceable to analytically prepared internal material, which in turn is traceable to gas-chromatography-mass spectroscopy (GC-MS). Assigned reference calibrators and MCMs are used for value assignment.
8. Sample Size for the Training Set
Not applicable. This describes an in vitro diagnostic material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
ADVIA Centaur® Ferritin (FER) Master Curve Material
1. Table of Acceptance Criteria and Reported Device Performance (Stability Studies)
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Real Time/Shelf Life (Unopened) | Dose recovery for MCM1 ≤ 0.5 ng/mL; For MCM2-8, % dose recovery met sponsor's required criteria. | Sponsor's acceptance criteria for the real-time stability study were met up to the 9 months' time point, supporting a shelf-life claim of 8 months (stored at 2-8°C). |
| On-Board Stability | Dose recovery for MCM1 ≤ 0.5 ng/mL; For MCM2-8, % dose recovery met sponsor's required criteria. | Sponsor's acceptance criteria for the on-board stability study were met up to 5 hours, supporting an on-board stability claim for 4 hours. |
| Value Assignment | New MCM doses must fall within the final value assignment specification for FER MCMs. Mean MCM doses of the new MCM lot must fall within customer range specifications. | Value assignment testing was conducted per the sponsor's procedure on the ADVIA Centaur XP system and met the pre-defined sponsor's acceptance criteria. MCM1 (analyte-free) measures at or below the Ferritin assay sensitivity limit. MCM8 (diluted with MCM1) meets the reportable range. (Quantitative results not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Real Time/Shelf Life (Unopened): Test FER MCMs were stored unopened. Time points: T=0, 3 months, 7 months, 8 months, and 9 months.
- On-Board Stability: Pooled aliquots of test FER MCMs in sample cups. Time points: T=0, 2, 4, and 5 hours.
- Value Assignment: Performance verification run consisting of 6 replicates of each MCM level.
- Data Provenance: Not explicitly stated, but assumed to be prospective internal Siemens Healthcare Diagnostics Inc. study data, likely from a lab in the USA (given the applicant's address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a quality control material which uses analytical comparisons against reference materials and manufacturer-defined specifications, not expert interpretation of results.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a quality control material, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study (Algorithm Only)
The device itself is a material, not an algorithm. The performance studies evaluate the stability and value assignment of the material based on the analytical results generated by the ADVIA Centaur XP system. These studies can be considered standalone evaluations of the material's properties.
7. Type of Ground Truth Used
- Stability Studies: Comparison of dose recoveries to -80°C stored reference MCMs.
- Value Assignment: Traceable to internal material that is standardized against World Health Organization (WHO) 2nd International Standard (WHO 80/578) reference material. Assigned reference calibrators and MCMs are used for value assignment.
8. Sample Size for the Training Set
Not applicable. This describes an in vitro diagnostic material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.