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510(k) Data Aggregation
(29 days)
The ADVIA Centaur® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin assay.
The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Cortisol assay.
ADVIA Centaur® Prolactin Master Curve Material is an in vitro diagnostic product containing various levels of prolactin spiked in lyophilized equine serum with sodium azide (0.1%) and preservatives including amphotericin B. Each set contains ten levels (MCM1–10); with a reconstituted volume of 1.0 mL per level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 2.11, 4.61, 9.21, 26.0, 51.1, 82.9, 113, 161, and 218 ng/mL.
ADVIA Centaur® Cortisol Master Curve Materials is an in vitro diagnostic product containing various levels of cortisol in lyophilized human plasma with sodium azide. Each set contains seven lyophilized levels (MCM1-7); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The COR MCMs assigned values are lot-specific of target values: 0.00, 1.00, 2.00, 6.00, 12.0, 30.0, and 80.0 µg/dL.
The provided text describes the acceptance criteria and supporting studies for two Master Curve Materials (MCMs): ADVIA Centaur Prolactin (PRL) MCM and ADVIA Centaur Cortisol (COR) MCM. These materials are intended for in vitro diagnostic use in verifying the calibration and reportable range of their respective assays.
Here's a breakdown of the requested information:
ADVIA Centaur Prolactin (PRL) Master Curve Material
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Stability | ||
| Real Time/Shelf Life (Unopened) | Dose recovery for MCM1 and % dose recovery for MCM2-10 met the requirements of the acceptance criteria and no adverse trends. | Met up to the 30 months' time point, supporting a shelf-life claim of 29 months when stored at 2-8°C. |
| In-Use Open Vial (Reconstituted) | Dose recovery for MCM1 and the % dose recovery MCM2-10 met the requirements of the acceptance criteria. | Met to the 29 days' time point, supporting an open vial claim of 28 days when properly stored at 2-8°C. |
| On-Board | Dose recovery for MCM1 and the % dose recovery for MCM2-10 met the requirements of the acceptance criteria. | Met up to 5 hours, supporting an on-board stability claim for 4 hours. |
| Value Assignment | MCM1 measures at or below the PRL assay sensitivity limit. New MCM doses fall within the final value assignment specification for PRL MCMs. Mean MCM doses of the new MCM lot fall within the customer range specifications. | MCM1 target is 0.0 dose and is analyte-free. MCMs are manufactured using qualified materials and measurement procedures. New MCM doses are calculated based on the relationship between observed reference MCM dose and its assigned value using a two-point calibration. Performance verification runs ensure mean MCM doses fall within customer range specifications. (Specific quantitative results for individual lots are lot-specific as shown in Table 2, page 9). |
| Expected Values | Lot-specific assigned values and lot-specific customer ranges established per % interval (MCM1: N/A, MCM2: 40%, MCM3-MCM9: 25%, MCM10: 20%). | Example lot-specific target and assigned values are provided, demonstrating adherence to the defined intervals (e.g., Table 2). The assay range is 0.3–200 ng/mL. |
| Traceability | The ADVIA Centaur Prolactin assay is traceable to World Health Organization (WHO) 3rd IRP for Prolactin (84/500). Assigned values for calibrators and MCMs are traceable to this standardization. The PRL MCMs are manufactured using qualified materials and measurement procedures. | The PRL MCMs are traceable to WHO 3rd IRP for Prolactin (84/500) through internal material standardized against it. MCMs are manufactured using qualified materials and measurement procedures. |
2. Sample size used for the test set and the data provenance:
- Real Time/Shelf Life (unopened): Test PRL MCMs stored unopened. Tested at T=0, 12 months, and 30 months. The sample size for each time point is not explicitly stated in terms of number of individual units, but it's implied that multiple samples were tested to establish dose recovery.
- In-Use Open Vial (reconstituted): Reconstituted PRL MCMs, each level pooled, aliquotted, and stored at 2-8°C. Tested in 5 replicates per level at T=0, 7, 14, 21, 28, and 29 days. (10 levels * 5 replicates * 6 time points = 300 measurements total, minimum).
- On-Board Stability: Pooled aliquots of test PRL MCMs in sample cups. Measured at T=0, 2, 4, and 5 hours. Sample size not explicitly stated for number of individual units, but likely multiple measurements per time point.
- Value Assignment Test Set: For a new PRL MCM lot, MCM1 is run in 5 replicates on two separate runs. MCM2-MCM10 were tested on 20 replicates in total (one run and four sample cups run in 5 replicates). Performance verification run used 6 replicates of each MCM level.
- Data Provenance: The studies were conducted by Siemens Healthcare Diagnostics, Inc. The data is retrospective for the purpose of demonstrating the device's performance for this 510(k) submission. Country of origin not explicitly stated, but the manufacturer is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are in vitro diagnostic materials used for calibration verification, not for making clinical diagnoses based on subjective expert review. The "ground truth" for the MCMs is established by their formulation (analyte-free for MCM1, spiked levels for others) and traceability to recognized standards (WHO 3rd IRP for Prolactin 84/500) and internal reference materials.
4. Adjudication method for the test set:
Not applicable for this type of device and study. Performance is assessed against quantitative, pre-defined acceptance criteria, not through expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in vitro diagnostic (IVD) material, not an AI-powered diagnostic device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an IVD material, not an algorithm. Its performance is evaluated intrinsically through stability and value assignment studies on an automated analyzer (ADVIA Centaur system).
7. The type of ground truth used:
The ground truth for the PRL MCMs is primarily based on:
- Traceability to International Standards: Specifically, the World Health Organization (WHO) 3rd International Reference Preparation (IRP) for human Prolactin 84/500.
- Analytical Procedures: MCMs are manufactured using qualified materials and measurement procedures, and for MCMs 2-10, known concentrations of prolactin are spiked into a matrix. MCM1 is analyte-free basepool.
- Value Assignment: Reference calibrators are prepared using Prolactin stock traceable to the WHO standard. The MCMs are value assigned against these reference calibrators using a nested testing run protocol to account for system and run variation.
8. The sample size for the training set:
Not applicable. This is an IVD material, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
ADVIA Centaur Cortisol (COR) Master Curve Material
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Stability | ||
| Real Time/Shelf Life (Unopened) | Dose recovery for MCM1 and % dose recovery for MCM2-7 met the requirements of the acceptance criteria and no adverse trends. | Met up to the 23 months' time point, supporting a shelf-life claim of 22 months when stored at 2-8°C. |
| In-Use Open Vial (Reconstituted) | Dose recovery for MCM1 and % dose recovery for MCM2-7 met the requirements of the acceptance criteria. | Met to the 15 days' time point, supporting an open vial claim of 14 days when properly stored at 2-8°C. |
| On-Board | Dose recovery for MCM1 and % dose recovery for MCM2-7 met the requirements of the acceptance criteria. | Met up to 5 hours, supporting an on-board stability claim for 4 hours. |
| Value Assignment | MCM1 measures at or below the Cortisol assay sensitivity limit. New MCM doses fall within the final value assignment specification for COR MCMs. Mean MCM doses of the new MCM lot fall within the customer range specifications. | MCM1 target is 0.0 dose and is analyte-free. MCMs are manufactured using qualified materials and measurement procedures. New MCM doses are calculated based on the relationship between observed reference MCM dose and its assigned value using a two-point calibration. Performance verification runs ensure mean MCM doses fall within customer range specifications. (Specific quantitative results for individual lots are lot-specific as shown in Table 2, page 16). |
| Expected Values | Lot-specific assigned values and lot-specific customer ranges established per % interval (MCM1: N/A, MCM2: 35%, MCM3-MCM6: 30%, MCM7: 20%). | Example lot-specific target and assigned values are provided, demonstrating adherence to the defined intervals (e.g., Table 2). The assay range is 0.20–75 µg/dL. |
| Traceability | The ADVIA Centaur Cortisol assay is standardized using internal standards manufactured analytically which are traceable to gas chromatography-mass spectroscopy (GCMS). Assigned values for calibrators and MCMs are traceable to this standardization. The COR MCMs are manufactured using qualified materials and measurement procedures. | The COR MCMs are traceable to gas chromatography-mass spectroscopy (GCMS) through analytically prepared internal materials. MCMs are manufactured using qualified materials and measurement procedures. |
2. Sample size used for the test set and the data provenance:
- Real Time/Shelf Life (unopened): Test COR MCMs stored unopened. Tested at T=0, 12 months, 18 months, and 23 months. The sample size for each time point is not explicitly stated in terms of number of individual units, but it's implied that multiple samples were tested to establish dose recovery.
- In-Use Open Vial (reconstituted): Reconstituted COR MCMs, each level pooled, aliquotted, and stored at 2-8°C. Tested in 5 replicates per level at T=0, 2, 4, 7, 11, 14, and 15 days. (7 levels * 5 replicates * 7 time points = 245 measurements total, minimum).
- On-Board Stability: Pooled aliquots of test COR MCMs in sample cups. Measured at T=0, 2, 4, and 5 hours. Sample size not explicitly stated for number of individual units, but likely multiple measurements per time point.
- Value Assignment Test Set: For a new COR MCM lot, MCM1 is run in 5 replicates on two separate runs. MCM2-MCM7 were tested on 20 replicates in total (one run and four sample cups run in 5 replicates). Performance verification run used 6 replicates of each MCM level.
- Data Provenance: The studies were conducted by Siemens Healthcare Diagnostics, Inc. The data is retrospective for the purpose of demonstrating the device's performance for this 510(k) submission. Country of origin not explicitly stated, but the manufacturer is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are in vitro diagnostic materials used for calibration verification, not for making clinical diagnoses based on subjective expert review. The "ground truth" for the MCMs is established by their formulation (analyte-free for MCM1, spiked levels for others) and traceability to recognized standards (GCMS) and internal reference materials.
4. Adjudication method for the test set:
Not applicable for this type of device and study. Performance is assessed against quantitative, pre-defined acceptance criteria, not through expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in vitro diagnostic (IVD) material, not an AI-powered diagnostic device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an IVD material, not an algorithm. Its performance is evaluated intrinsically through stability and value assignment studies on an automated analyzer (ADVIA Centaur system).
7. The type of ground truth used:
The ground truth for the COR MCMs is primarily based on:
- Traceability to Reference Methods: Specifically, gas chromatography-mass spectroscopy (GCMS) through analytically prepared internal standards.
- Analytical Procedures: MCMs are manufactured using qualified materials and measurement procedures, and for MCMs 2-7, known concentrations of cortisol are spiked into a matrix. MCM1 is analyte-free basepool.
- Value Assignment: Reference calibrators are prepared using cortisol stock traceable to GCMS. The MCMs are value assigned against these reference calibrators using a nested testing run protocol to account for system and run variation.
8. The sample size for the training set:
Not applicable. This is an IVD material, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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