(28 days)
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
The document describes stability studies as the performance data. Regulatory filings for this type of product often focus on demonstrating that the control material remains stable and performs as expected over time, showing "precision" in monitoring laboratory tests. The acceptance criteria aren't explicitly stated as numerical targets in a table, but rather implied through the successful completion of these stability studies to support specific product claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reconstituted Stability: Maintain stability for specified time/temperature for all analytes. | All analytes stable for 8 hours at 2°C to 25°C, with Protein S stable for 8 hours at 2°C to 8°C. |
| Shelf Life: Maintain stability for a specified duration under storage conditions. | Three years when stored at 2°C to 8°C. (Real-time studies ongoing to support this claim). |
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "stability studies have been performed," but does not provide details on the number of control units tested, or the frequency/duration of testing within the stated stability periods.
- Data Provenance: Not explicitly stated, though it would be from the manufacturer's (Bio-Rad Laboratories) internal testing as implied by "All supporting data is retained on file at Bio-Rad Laboratories." The country of origin of the data is therefore likely USA. The studies are prospective in nature, as they are establishing future shelf-life and reconstituted stability claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of study (stability testing of a quality control plasma) does not typically involve human expert adjudication in the same way an image analysis device would. The "ground truth" is established through analytical methods in a laboratory setting, comparing results from the control material to established reference values or predicate device performance. Therefore, no "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for individual data points from the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinion, typically in diagnostic or screening scenarios. For a quality control product's stability study, performance is measured against established analytical methods and specifications, not subjective expert reviews.
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:
- Not applicable. This device is a quality control plasma, not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laboratory reagent (control plasma) and does not involve an algorithm. Its "performance" is its ability to provide consistent and accurate results when used in laboratory instruments to monitor the precision of other assays.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for evaluating the stability and performance of the Lyphochek® Hemostasis Control would be analytical reference values and established performance characteristics of the analytes within the plasma. This means that at specified time points, the levels of PT, APTT, Fibrinogen, etc., are measured using validated laboratory methods, and these measurements are compared against the expected values and acceptable ranges determined during product development and characterization, often with reference to predicate devices.
8. The sample size for the training set:
- Not applicable. This device is a physical control material, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. Product development and characterization would involve extensive testing, but this is distinct from training a model.
9. How the ground truth for the training set was established:
- 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.