Search Results
Found 1 results
510(k) Data Aggregation
(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 < 0.02 dose - MCM2-5: % dose recovery within 85% to 115% calculated to Time=0 | Acceptance criteria were met up to 5 hours, supporting an on-board stability claim for 4 hours. |
| Value Assignment (New Lot Release) | - New MCM doses must fall within the final value assignment specification for TnI-Ultra MCMs. - Mean MCM doses of the new TnI-Ultra MCM lot manufactured must fall within the release range specifications (which are 5% tighter than customer ranges). - MCM1 range is claimed as "<" less than 3X the limit of sensitivity (≤0.018 ng/mL) of the ADVIA Centaur TnI-Ultra assay. | The document states that "The new MCM doses must fall within the final value assignment specification for TnI-Ultra MCMs" and "The mean MCM doses of the new TnI-Ultra MCM lot manufactured must fall within the release range specifications," implying these criteria are met for manufactured lots. An example lot-specific assigned value and range table is provided, demonstrating how these values would be presented and indicating successful assignment for a sample lot. MCM1 is assigned 0.0 dose and the range is < 0.018 ng/mL, meeting the <3X limit of sensitivity claim. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Real Time/Shelf Life (Unopened): Samples were tested at T=0, 3 months, and 10 months. The number of replicates per time point is not explicitly stated, but the study "supports a shelf-life claim of 9 months." Data provenance is assumed to be internal laboratory data, prospective (as it's a real-time study). No country of origin is specified beyond general Siemens Healthcare Diagnostics Inc. information.
- In Use (Open Vial) @ 2-8°C (Reconstituted): Each level tested in 5 replicates per level at T=0, 2, 4, 6, 8, 9, 24, and 25 hours.
- In Use (Open Vial) @ -20°C (Reconstituted): Each level tested in 5 replicates per level at Day=0, 14, 28, 35, 45, 60, and 63 days.
- On-Board Stability: Each level tested at T=0, 2, 4, and 5 hours. The number of replicates per level is not explicitly stated.
- Value Assignment:
- MCM1: 5 replicates on two separate runs.
- MCM2-MCM5: 20 replicates in total (one run, four sample cups run in 5 replicates).
- Performance Verification Run: 6 replicates of each MCM level.
Data provenance for all these studies is internal Siemens laboratory data, prospective in nature as they are performance characteristic studies for the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a quality control material intended for verification of calibration and reportable range for an assay. Its performance is assessed against defined analytical criteria, not against clinical expert interpretations of patient data. The "ground truth" here is the result from reference calibrators and defined analytical specifications, not expert consensus on patient conditions.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication of clinical cases is involved. Performance is based on predefined analytical acceptance criteria compared to measured values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is not relevant for a quality control material.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance studies described are essentially "standalone" in that they evaluate the analytical performance of the Master Curve Material itself, independent of human interpretation of clinical outcomes. The device is a reagent, and its performance is measured directly by an automated system (ADVIA Centaur system).
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on:
- Pre-defined analytical specifications and acceptance criteria for dose recovery and stability.
- Comparison against T=0 dose recovery results for stability studies.
- Comparison against freshly reconstituted -80°C stored MCM average dose results for "in use" stability.
- Traceability to NIST SRM 2921 and highly purified internal materials for value assignment.
- The "target for MCM1 is assigned a 0.0 dose" without a statistical method, and its range is less than 3 times the limit of sensitivity.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material and does not involve an "algorithm" in the sense of machine learning that requires a training set. The "training" for such a product would be its manufacturing and validation process to meet specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
ADVIA Centaur® Digoxin 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 ≤ 0.10 dose - MCM2: % dose recovery within 82% to 118% - MCM3-6: % dose recovery within 85% to 115% calculated to Day 0 - No adverse trends | Acceptance criteria were met up to the 33 months' time point, supporting a shelf-life claim of 32 months. |
| Stability: In Use (Open Vial) @ 2-8°C (Reconstituted) | - MCM1: Dose recovery ≤ 0.10 dose (versus -80°C stored MCM1 average dose) - MCM2: % dose recovery within 82% to 118% (versus -80°C stored MCM2 average dose) - MCM3-6: % dose recovery within 85% to 115% (versus -80°C MCMs 3-6 average dose) | Acceptance criteria were met up to the 29 days' time point, supporting an open vial claim of 28 days when stored at 2-8°C. |
| Stability: On-Board | - MCM1: Dose recovery ≤ 0.10 dose - MCM2: % dose recovery within 82% to 118% - MCM3-6: % dose recovery within 85% to 115% calculated to T=0 | Acceptance criteria were met up to 5 hours, supporting an on-board stability claim for 4 hours. |
| Value Assignment (New Lot Release) | - New MCM doses must fall within the final value assignment specification for Digoxin MCMs. - Mean MCM doses of the new Digoxin MCM lot manufactured must fall within the release range specifications (which are 5% tighter than customer range specifications). - MCM1 range is claimed as "<" less than 3X the limit of sensitivity (≤ 0.1 ng/mL) of the ADVIA Centaur Digoxin assay. | The document states that "The new MCM doses must fall within the final value assignment specification for Digoxin MCMs" and "The mean MCM doses of the new Digoxin MCM lot manufactured must fall within the release range specifications," implying these criteria are met for manufactured lots. An example lot-specific assigned value and range table is provided, demonstrating how these values would be presented and indicating successful assignment for a sample lot. MCM1 is assigned 0.0 dose and the range is < 0.300 ng/mL, meeting the <3X limit of sensitivity claim. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Real Time/Shelf Life (Unopened): Samples were tested at T=0, 12 months, 18 months, and 33 months. The number of replicates per time point is not explicitly stated. Data provenance is assumed to be internal laboratory data, prospective.
- In Use (Open Vial) @ 2-8°C (Reconstituted): Each level tested in 5 replicates per level at T=0, 7, 14, 21, 28, and 29 days.
- On-Board Stability: Each level tested at T=0, 2, 4, and 5 hours. The number of replicates per level is not explicitly stated.
- Value Assignment:
- MCM1: 5 replicates on two separate runs.
- MCM2-MCM6: 20 replicates in total (one run, four sample cups run in 5 replicates).
- Performance Verification Run: 6 replicates of each MCM level.
Data provenance for all these studies is internal Siemens laboratory data, prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a quality control material, and its performance is assessed against defined analytical criteria, not against clinical expert interpretations of patient data. The "ground truth" here is the result from reference calibrators and defined analytical specifications.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication of clinical cases is involved. Performance is based on predefined analytical acceptance criteria compared to measured values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is not relevant for a quality control material.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described are essentially "standalone" in that they evaluate the analytical performance of the Master Curve Material itself, independent of human interpretation of clinical outcomes. The device is a reagent, and its performance is measured directly by an automated system (ADVIA Centaur system).
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on:
- Pre-defined analytical specifications and acceptance criteria for dose recovery and stability.
- Comparison against T=0 dose recovery results for stability studies.
- Comparison against -80°C stored MCM average dose results for "in use" stability.
- Traceability to USP (United States Pharmacopeia) Digoxin stock and USP internal material for value assignment.
- The "target for MCM1 is assigned a 0.0 dose" without a statistical method, and its range is less than 3 times the limit of sensitivity.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material and does not involve an "algorithm" in the sense of machine learning that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1