(38 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 text describes the Liquichek™ D-dimer Control device, which is an assayed quality control intended to monitor the precision of laboratory testing procedures for D-dimer. It's important to note that this device is a control for D-dimer assays, not an D-dimer assay itself. Therefore, the "performance" here refers to its stability and ability to maintain stated analyte levels over time.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are related to its stability (open vial and shelf life). The "reported device performance" directly addresses these stability claims.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability: Maintain stability | 30 days when stored tightly capped at 2 to 25°C |
| Shelf Life: Maintain stability | Three years when stored at 2 to 8 °C |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample size: Not explicitly stated. The stability studies would have involved multiple vials/lots of the Liquichek™ D-dimer Control.
- Data provenance: Not explicitly stated, but implicitly prospective as it involves "stability studies" and "real time studies." The data would originate from Bio-Rad Laboratories.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the traditional sense for this device. The "ground truth" for a quality control material is its assigned value(s) for the analyte (D-dimer) and its stability over time. This is established through internal testing and measurement by the manufacturer (Bio-Rad Laboratories) using validated assays, not by external experts reviewing test results. There's no mention of experts establishing a ground truth for clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data and their disagreements need to be resolved. For a quality control device's stability study, there is no human interpretation or adjudication process of this nature. The results are quantitative measurements against established analytical methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reading scans) and AI might assist them. The Liquichek™ D-dimer Control is a quality control material, not a diagnostic tool where human readers are involved in interpreting its "output" to make a clinical decision.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This device is a consumable quality control material; it is not an algorithm or an AI system that would have a standalone performance. Its "performance" relates to its chemical and biological stability and its ability to provide consistent D-dimer values over its stated shelf life and open-vial period.
7. The Type of Ground Truth Used
The ground truth used for this device's performance (stability claims) is based on analytical measurements performed by the manufacturer, Bio-Rad Laboratories. These measurements would quantify the D-dimer levels within the control material over time, under specified storage conditions, using validated D-dimer assays. These are objective, quantitative laboratory results, not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This question is not applicable. The Liquichek™ D-dimer Control is not an AI/ML algorithm or a diagnostic test that requires a training set. Its manufacturing process involves formulation and quality control validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no training set for this type of medical device.
§ 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.