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510(k) Data Aggregation
(35 days)
The IMMULITE® Albumin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Albumin assay on the IMMULITE 2000 systems
The IMMULITE® Myoglobin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Myoglobin assay on the IMMULITE 2000 systems
The Albumin Calibration Verification Material (CVM) contains one set of four vials each 2.0 mL after reconstitution. CVM1 contains bovine protein with preservatives. CVM2, CVM3 and CVM4 contain various levels of human albumin in a bovine protein matrix with preservatives. The CVMs are supplied in lyophilized form.
IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM) contains one set of four vials each 2.0mL after reconstitution. CVM1 contains bovine serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of human cardiac myoglobin in bovine serum with preservatives. The CVMs are supplied in lyophilized form.
The provided documents describe the performance testing for two medical devices: the IMMULITE® 2000 Albumin Calibration Verification Material (CVM) and the IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM).
IMMULITE® 2000 Albumin Calibration Verification Material (CVM)
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as meeting the acceptance criteria, as stated in the stability summaries. The studies aimed to demonstrate that the CVM maintains optimal product performance within the established shelves life before and after reconstitution.
Table: Acceptance Criteria and Reported Device Performance for IMMULITE® 2000 Albumin CVM
| Test | CVM Level | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Shelf Life Stability | LHACVM1 | < 2.5 ug/mL (for assigned dose 0.00 ug/mL) | Stable up to 6 years at 2-8°C, meeting criteria. |
| LHACVM2 | ±10% difference from assigned dose (4.55-5.56 ug/mL for 5.05 ug/mL) | Stable up to 6 years at 2-8°C, meeting criteria. | |
| LHACVM3 | ±10% difference from assigned dose (18.6-22.8 ug/mL for 20.7 ug/mL) | Stable up to 6 years at 2-8°C, meeting criteria. | |
| LHACVM4 | ±15% difference from assigned dose (53.6-72.5 ug/mL for 63.0 ug/mL) | Stable up to 6 years at 2-8°C, meeting criteria. | |
| Open Vial Stability | LHACVM1 | ≤ 2.5 ug/mL (for assigned dose 0.00 ug/mL) | Stable up to 2 hours at 15-25°C, meeting criteria. |
| LHACVM2 | ±10% difference from initial time point dose (4.55-5.56 ug/mL for 5.05 ug/mL) | Stable up to 2 hours at 15-25°C, meeting criteria. | |
| LHACVM3 | ±10% difference from initial time point dose (18.6-22.8 ug/mL for 20.7 ug/mL) | Stable up to 2 hours at 15-25°C, meeting criteria. | |
| LHACVM4 | ±15% difference from initial time point dose (53.6-72.5 ug/mL for 63.0 ug/mL) | Stable up to 2 hours at 15-25°C, meeting criteria. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: For both Shelf Life Stability and Open Vial Stability, CVMs and reference CVMs were run in duplicate (as a minimum) at specified time points.
- Value Assignment & Reference Range: Each CVM level was tested on 27 replicates in total, comprised of 9 runs, 3 replicates per run, using 9 IMMULITE 2000 systems and 3 different reagent kit lots.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic product, it is most likely prospective testing conducted in-house by Siemens Healthcare Diagnostics.
3. Number of experts used to establish the ground truth for the test set and their qualifications
Not applicable. This device is a calibration verification material, not an AI/diagnostic algorithm that interprets patient data. The "ground truth" here refers to the assigned dose values and acceptable ranges based on manufacturing protocols and established analytical standards for the calibrators.
4. Adjudication method for the test set
Not applicable. This device is a calibration verification material.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. This device is a calibration verification material, not an AI diagnostic intended for human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the performance testing described measures the analytical performance of the CVM on the IMMULITE 2000 systems as an "algorithm only" (or rather, "device only") measurement of its stability and value assignment, without human interpretation as part of the primary outcome. The CVM's ability to verify calibration of the assay is its intended function.
7. The type of ground truth used
The ground truth for the CVMs is based on assigned dose values traceable to an internal material. For value assignment, the calibrators (and thus CVMs) are value-assigned using assigned reference calibrators prepared using Albumin antigen stock, traceable to an internal material. Validation of these value assignments involved commercially available controls and 23 urine samples.
8. The sample size for the training set
Not applicable for a CVM calibration material. The "training" here relates to the establishment of the assay's calibration curve, not an AI model.
9. How the ground truth for the training set was established
Not applicable for a CVM calibrator material. The "ground truth" for the calibrators and CVMs is established through gravimetric preparation and traceability to an internal standard as detailed in section 7.3 and 7.4.
IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM)
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as meeting the acceptance criteria, as stated in the stability summaries. The studies aimed to demonstrate that the CVM maintains optimal product performance within the established shelves life before and after reconstitution.
Table: Acceptance Criteria and Reported Device Performance for IMMULITE® 2000 Myoglobin CVM
| Test | CVM Level | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Shelf Life Stability | LMYCVM1 | ≤2.0 ng/mL (for assigned dose 0.00 ng/mL) | Stable up to 7 years at -20°C, meeting criteria. |
| LMYCVM2 | ±10% difference from assigned dose (23.9-29.3 ng/mL for 26.6 ng/mL) | Stable up to 7 years at -20°C, meeting criteria. | |
| LMYCVM3 | ±10% difference from assigned dose (104-128 ng/mL for 116 ng/mL) | Stable up to 7 years at -20°C, meeting criteria. | |
| LMYCVM4 | ±10% difference from assigned dose (945-1155 ng/mL for 1050 ng/mL) | Stable up to 7 years at -20°C, meeting criteria. | |
| Open Vial Stability | LMYCVM1 | ≤ 2.0 ng/mL (for assigned dose 0.00 ng/mL) | Stable up to 8 hours after reconstitution, meeting criteria. |
| LMYCVM2 | ±10% difference from initial time point dose (23.9-29.3 ng/mL for 26.6 ng/mL) | Stable up to 8 hours after reconstitution, meeting criteria. | |
| LMYCVM3 | ±10% difference from initial time point dose (104-128 ng/mL for 116 ng/mL) | Stable up to 8 hours after reconstitution, meeting criteria. | |
| LMYCVM4 | ±10% difference from initial time point dose (945-1155 ng/mL for 1050 ng/mL) | Stable up to 8 hours after reconstitution, meeting criteria. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: For both Shelf Life Stability and Open Vial Stability, CVMs and reference CVMs were run in duplicate (as a minimum) at specified time points.
- Value Assignment & Reference Range: Each CVM level was tested on 15 replicates in total, comprised of 5 runs, 3 replicates per run, using 3 IMMULITE 2000 systems and 4 different reagent kit lots.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic product, it is most likely prospective testing conducted in-house by Siemens Healthcare Diagnostics.
3. Number of experts used to establish the ground truth for the test set and their qualifications
Not applicable. This device is a calibration verification material, not an AI/diagnostic algorithm that interprets patient data.
4. Adjudication method for the test set
Not applicable. This device is a calibration verification material.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. This device is a calibration verification material, not an AI diagnostic intended for human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the performance testing described measures the analytical performance of the CVM on the IMMULITE 2000 systems as an "algorithm only" (or rather, "device only") measurement of its stability and value assignment, without human interpretation as part of the primary outcome. The CVM's ability to verify calibration of the assay is its intended function.
7. The type of ground truth used
The ground truth for the CVMs is based on assigned dose values traceable to an internal standard. For value assignment, the calibrators (and thus CVMs) are value-assigned using assigned reference calibrators prepared using Myoglobin antigen stock, traceable to an internal standard. Validation of these value assignments involved three levels of commercially available controls and 30 samples (25 spiked samples and 5 normal samples).
8. The sample size for the training set
Not applicable for a CVM calibration material. The "training" here relates to the establishment of the assay's calibration curve, not an AI model.
9. How the ground truth for the training set was established
Not applicable for a CVM calibrator material. The "ground truth" for the calibrators and CVMs is established through gravimetric preparation and traceability to an internal standard as detailed in section 7.3 and 7.4.
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