(34 days)
Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin III (AT III) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical and preservatives. The control is provided in lyophilized form for increased stability.
The provided document describes the Bio-Rad Laboratories Lyphochek® Coagulation Control (new device) and its substantial equivalence to a predicate device. The information focuses on the device's characteristics and stability, rather than a clinical study evaluating its performance against specific acceptance criteria for a diagnostic algorithm.
Therefore, the requested information elements related to a study proving the device meets acceptance criteria cannot be fully extracted from this document in the typical sense of an AI/ML device study. However, I can interpret "acceptance criteria" here as the performance specifications the manufacturer claims for the device based on their internal testing (stability studies).
Here's an analysis based on the provided text, addressing the points where information is available and noting when it's not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Open Vial Stability (Reconstituted state) | All analytes stable for 24 hours when stored tightly capped at 2-8°C |
| Shelf Life (Unopened, Lyophilized state) | Two years when stored at 2-8°C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Stability studies" being performed. This implies internal testing of the manufactured control lots.
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The data would be considered prospective for the specific lots tested during the stability studies, but not a "test set" in the context of an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable to this type of device. The Lyphochek® Coagulation Control is a quality control material, not a diagnostic device that requires expert interpretation or ground truth establishment in a clinical study setting. The performance is determined by instrumental measurements according to known scientific principles in a laboratory setting.
4. Adjudication Method for the Test Set
- This is not applicable to this type of device. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or complex diagnostic outcomes where multiple experts might disagree.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the effectiveness of human readers (with vs. without AI assistance) in diagnostic tasks, which is not the function of a coagulation control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a quality control material and does not involve an algorithm that performs a diagnostic task independently.
7. Type of Ground Truth Used
- The "ground truth" for the performance of this control material is based on established analytical methods for coagulation assays (Prothrombin Time, aPTT, Fibrinogen, Antithrombin III, Thrombin Time). The expected values and stability are determined through rigorous laboratory testing using calibrated instruments and reference methods, not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
8. Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not use an AI/ML algorithm.
§ 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.