(67 days)
The Multichem WBT control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.
Technopath has developed whole blood control materials prepared from human whole blood, to which whole blood purified biochemical material (extracts of human origin), chemicals, drugs, preservatives and stabilizers have been added. Three levels of control are available to allow performance monitoring within the analytical range.
The provided document is a 510(k) summary for the Multichem WBT control, a quality control material used to monitor the precision of laboratory testing procedures for specific analytes (Cyclosporine, Sirolimus, Tacrolimus).
It describes the device, its intended use, comparison to a predicate device, and performance characteristics focused on traceability, value assignment, and stability. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a ground truth through a clinical study involving human readers or standalone algorithm performance.
The "performance characteristics" detailed in the document refer to:
- Traceability Summary: States the analytes are from commercial sources or endogenous to the base matrix, and no claim of traceability to higher order reference materials is made. This is not a measure of accuracy against a clinical ground truth.
- Value Assignment Summary: Describes how typical values for the control material were determined using an Abbott ARCHITECT i2000 chemistry system. It involved 2 reagent lots, 2 calibrator lots, 16 runs (32 data points), and 8 calibration events. The "predetermined criteria of 30% around the grand mean" was used to establish value assignment ranges, and all values fell within these ranges. This is about establishing the expected range for the control itself, not about its diagnostic accuracy or impact on human performance.
- Stability Testing Summary: Details open-vial and shelf-life stability studies. Open-vial stability was assessed using CLSI EP25A, with a maximum allowable drift (degradation) of 10% to determine the point of failure. Shelf-life was supported by accelerated and preliminary real-time testing using CLSI EP25A, also with a 10% drift limit, predicting stability for 30 months. This relates to the product's physical and chemical integrity over time, not its performance in a diagnostic context.
Since the device is a quality control material, the typical metrics for a diagnostic device (like sensitivity, specificity, reader performance) are not applicable in this context. The "performance" here refers to the consistency and stability of the control material itself.
Therefore, the requested information elements cannot be fully addressed in the format of a typical diagnostic device study due to the nature of the device (a quality control material).
However, I can extract the relevant information where it exists:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | Value assignment ranges established at 30% around the grand mean. | Values for the lots tested all fell within the established ranges. |
| Open Vial Stability | Maximum allowable drift (degradation) of 10%. | Tacrolimus & Cyclosporine: 10 days at 2 to 8ºC. |
| Sirolimus: 7 days at 2 to 8ºC. | ||
| Shelf-Life Stability | Drift Limit of 10% for accelerated and preliminary real-time testing. | Predicted to be stable for in excess of 30 months when stored at -20°C to -80°C. (Real-time testing is ongoing). Product claim: 30 months at -20° to -80°C. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Value Assignment:
- Test Set Sample Size: 32 data points (replicates from 16 runs)
- Data Provenance: Not explicitly stated, but performed internally by Technopath. Implied prospective as it was done to determine typical values for the product.
- Stability Testing:
- Test Set Sample Size: "Multiple time points" tested for open-vial stability; three lots of controls for accelerated testing; three lots of controls for preliminary real-time testing.
- Data Provenance: Not explicitly stated, but performed internally by Technopath. Prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable (N/A): This device is a quality control material, not a diagnostic device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for this device relates to its chemical properties and performance on a specific analytical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: As above, this is not a diagnostic device requiring adjudication of expert interpretations.
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
- N/A: This is not a diagnostic device, and thus no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This is a physical quality control material, not an algorithm. Its performance is measured through its interaction with an analytical instrument (Abbott ARCHITECT i2000).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Value Assignment: The "truth" is an internally determined grand mean, against which individual measurements were compared to establish ranges. This is a form of internal reference standard based on instrument performance.
- Stability Testing: The "truth" is the initial established value of the control material, and subsequent measurements over time are compared against this initial value to determine drift/degradation.
8. The sample size for the training set
- N/A: This device is a quality control material and does not involve AI model training. The performance studies described are for quality control and stability, not for training a predictive model.
9. How the ground truth for the training set was established
- N/A: As there is no training set for an AI model, this is not applicable.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.