(39 days)
Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.
Liquichek™ D-dimer Control is prepared from processed human plasma with added constituents of human and animal origin, and preservatives. The control is provided in liquid form for convenience.
The provided document describes the Bio-Rad Liquichek™ D-dimer Control, a quality control product, and its substantial equivalence to a predicate device. This submission focuses on the product's performance attributes and comparative analysis rather than a traditional medical device (e.g., diagnostic AI algorithm) for which acceptance criteria and a study proving those criteria are typically described.
Therefore, the requested information elements (1-9) which are typically associated with performance studies of diagnostic devices with clinical outcomes, are not directly applicable in the same way to this quality control product. However, I can interpret the provided information to best fit the requested structure, focusing on the stability studies mentioned as the primary "study" performed for this device.
Here's an interpretation based on the provided document:
Acceptance Criteria and Study Details for Liquichek™ D-dimer Control
This submission focuses on establishing the substantial equivalence of a new multi-level quality control product to an existing bi-level product and evaluating its stability. The "performance" being assessed here is the control's stability over time, which is critical for its intended use in monitoring laboratory precision.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly related to the stability claims. The reported performance is the established stability period.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open Vial Stability: Control maintains its stated D-dimer levels and integrity for a specified period after opening. | 30 days when stored tightly capped at 2 to 25°C. |
| Shelf Life (Unopened Vial Stability): Control maintains its stated D-dimer levels and integrity for a specified period when unopened. | Three years when stored at 2 to 8 °C. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of how many individual vials or batches were tested for the stability studies. However, it indicates:
- Sample Size: Not explicitly stated (e.g., number of batches, number of vials per batch).
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The country of origin for the data is not specified, but the submitter is Bio-Rad Laboratories, located in Irvine, California, USA. The studies are prospective as they are described as "stability studies have been performed" and "Real time studies will be ongoing to support the shelf life."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a quality control product, "ground truth" and "experts" in the context of clinical interpretation are not directly applicable. The "truth" is established by the analytical methods used to determine the D-dimer levels and the product's stability characteristic.
- Number of Experts: Not applicable in the context of clinical interpretation.
- Qualifications of Experts: Not applicable. The "expertise" lies within the analytical chemistry and quality control professionals at Bio-Rad who designed and executed the stability testing.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1) are not applicable to the stability testing of a quality control product. The stability is determined through laboratory measurements and statistical analysis against predefined acceptance limits for D-dimer values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, which is not the primary focus for a quality control product.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
While this is not an "algorithm," the stability studies represent a standalone performance assessment of the control material itself, without direct human interpretation of clinical cases within the study design. The "performance" here is the material's ability to maintain its specified characteristics over time.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies is effectively the assigned D-dimer value for each level of the control product and the measured D-dimer levels over time using validated analytical methods. The stability is confirmed if the measured values remain within predefined acceptance limits (which would be internal specifications based on assay precision and clinical relevance). This is akin to using analytical reference values/measurements.
8. The Sample Size for the Training Set
"Training set" is not applicable for a quality control product's stability studies in the way it would be for an AI algorithm. There is no machine learning model being trained. The "training" here would be the development and optimization of the manufacturing process and initial characterization of the product.
9. How the Ground Truth for the Training Set was Established
As "training set" is not applicable in the AI sense, this question is also not directly relevant. The "ground truth" for establishing the initial characteristics of the control (before stability testing) would come from rigorous analytical testing using reference methods and potentially comparison to international standards for D-dimer measurement. These assigned values then form the basis against which stability is assessed.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.