(23 days)
Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemicals (tissue extract from animal origin), and preservatives. The control is provided in lyophilized form for increased stability.
Here's a breakdown of the acceptance criteria and the study details for the Lyphochek® Coagulation Control Level 4, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Claim) | Reported Device Performance |
|---|---|
| Open Vial Stability: All analytes stable for 24 hours at 2-25°C | Implied to meet this criterion for all analytes (Studies performed, data on file) |
| Shelf Life: Three years when stored at 2-8°C | Three years when stored at 2-8°C |
Note: The document states that stability studies were performed to determine these claims, and all supporting data is retained on file at Bio-Rad Laboratories. It does not explicitly present a table comparing measured values against a predefined acceptable range, but rather asserts that the product meets these stability claims based on the studies.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the stability studies. It only mentions that "Stability studies have been performed."
Regarding data provenance:
- Country of Origin: Not specified in the provided document.
- Retrospective or Prospective: Not specified, but stability studies are typically prospective, involving monitoring the product over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device (quality control plasma). The "ground truth" for a coagulation control is its inherent stability and performance characteristics, which are determined through laboratory testing using various coagulation systems, not through expert consensus or interpretation of images/data by human experts.
4. Adjudication Method
This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, where multiple reviewers' opinions need to be reconciled (e.g., in medical image analysis).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed and is not applicable to this device. This type of study assesses how human readers' performance changes with AI assistance, which is irrelevant for a laboratory reagent like a coagulation control.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop performance) was not explicitly detailed as such, but the stability studies performed on the Lyphochek® Coagulation Control Level 4 represent its "standalone" performance. The device itself is a control material, and its performance is evaluated directly through laboratory testing using established coagulation methods (PT, APTT, Fibrinogen, AT III, TT), not through an algorithm or human-in-the-loop assessment.
7. Type of Ground Truth Used
The ground truth used for evaluating the device would be the measured values of the coagulation analytes (Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, Antithrombin III, Thrombin Time) over time, compared against expected ranges or reference values for a stable product. This is essentially laboratory test results and established analytical methods.
8. Sample Size for the Training Set
This information is not applicable. This device is a biochemical reagent, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of 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.