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510(k) Data Aggregation
(20 days)
The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista System.
The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista™ System.
ALP CAL is liquid bovine protein based product containing alkaline phosphatase from porcine kidney. The kit consists of three vials (Calibrator A, Level 2) which are ready for use (no preparation is required). The volume per vial is 1.0 mL. System water is used as the ALP zero calibrator (Level 1) for the Dimension VistaTM System.
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista™ System Alkaline Phosphatase Calibrator (ALP CAL - KC330), based on the provided text:
Important Note: The provided document is a 510(k) summary for a calibrator, which is a reference material used to ensure the accuracy of a diagnostic test. Therefore, the "device performance" and "acceptance criteria" discussed here relate to the calibrator's stability and value assignment, not the performance of a diagnostic test for a patient condition. This type of device does not involve expert readers, comparative effectiveness studies (MRMC), or a ground truth established from pathology/outcomes data in the same way as an imaging or diagnostic algorithm would.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life Stability | Allowable shelf life percent change should be $\leq$ 6% (comparing 4°C stored product to -70°C control). Target shelf life is 12 months. | "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." (This implies the real-time data supported the 12-month shelf life and met the ≤ 6% change criterion, though the specific data is not explicitly shown in this summary.) |
| On-board Stability | A vial punctured by the instrument and stored on board is stable for seven days. | The summary states this is the reported stability, implying that testing confirmed stability for this duration. (Specific data not provided in summary). |
| Opened Vial Stability (Recapped, Refrigerated) | An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days. | The summary states this is the reported stability, implying that testing confirmed stability for this duration. (Specific data not provided in summary). |
| Value Assignment (New Master Pool) | Concentrations are verified "using a previously approved Master Pool lot as a control." (Implicitly, the new Master Pool must agree with the control within acceptable limits). The final bottle value is assigned after N=45 replicates on multiple instruments. | The new calibrator Master Pool concentrations are verified using a previously approved Master Pool lot. The final bottle value is assigned for each level by testing N=45 replicates on multiple instruments. (Performance is that this process was followed and values were assigned). |
| Value Assignment (Commercial Lot) | The stock solution concentration is verified by comparing the Master Pool assigned bottle values. The commercial lot's concentration is verified to be "within acceptable range" using an instrument calibrated with Master Pools. The final bottle value is assigned and verified using a previously released commercial lot on multiple instruments for N=45 total replicates. | The stock solution concentration for the new commercial calibrator lot is verified by comparing Master Pool assigned bottle values. The commercial lot concentration is verified to be within acceptable range. The final bottle value is assigned and verified using a previously released commercial lot on multiple instruments for N=45 total replicates. (Performance is that this process was followed and values were assigned within acceptable limits). |
Study Details:
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set for Shelf-life Stability: The summary mentions comparing the product stored at 4°C with a control stored at -70°C. The sample size for this real-time stability study is not explicitly stated as a number of vials or batches, but implies ongoing monitoring.
- Test Set for Opened Vial Stability: Vials are opened/punctured on day zero and re-tested on days 0, 8, 15, 22, and 32. The number of vials or replicates for this testing is not specified.
- Test Set for Value Assignment: N = 45 replicates were used on multiple instruments for both the Master Pool and commercial lot value assignments.
- Data Provenance: The studies were conducted by Dade Behring, Inc. (Newark, DE, USA). The data is from prospective stability studies and internal value assignment processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable in the typical sense. This device is a calibrator, not a diagnostic test for a patient condition. The "ground truth" here is the assigned value of the calibrator, which is established through a rigorous, traceable protocol (gravimetric additions, comparison to approved Master Pools, multiple replicates on instruments) rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3. The "adjudication" is inherent in the robust statistical process of value assignment involving N=45 replicates and comparison to established references.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, not specified. This type of study is typically for evaluating the performance of diagnostic algorithms or imaging interpretations where human readers are involved. As a calibrator, it doesn't fit this paradigm.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The performance of the calibrator and its assigned values are determined analytically and statistically, independent of human interpretation or assistance in the final "performance" measure. The "device performance" refers to the calibrator's stability and accuracy of its assigned value, which is intrinsic to the material itself and how accurately its concentration can be determined by instruments.
7. The Type of Ground Truth Used:
- The "ground truth" for the calibrator's assigned value is established through:
- Gravimetric addition: Precisely weighing the alkaline phosphatase component to create target concentrations.
- Traceability to Master Pool, Dimension® clinical chemistry system values: The values are linked to a primary reference standard.
- Comparison to previously approved reference lots: Both Master Pool and commercial lot assays refer back to established, validated materials.
8. The Sample Size for the Training Set:
- Not applicable in the typical sense. Calibrators do not have a "training set" in the way a machine learning algorithm would. The process involves creating material with a known concentration, then verifying that concentration. The "training" aspects are the established protocols and reference materials used in the manufacturing and value assignment processes.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8. The "ground truth" for the calibrator's value is established through gravimetric preparation (precisely measured ingredients) and analytical verification against established, traceable reference materials and protocols.
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