(37 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 constituents of animal origin, purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
This document is a 510(k) summary for the Lyphochek Coagulation Control device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance for a novel AI/software-based device.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission for a laboratory control product.
Here's a breakdown of what can be extracted and what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific quantitative "acceptance criteria" in the way one would for a diagnostic test with metrics like sensitivity or specificity. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the new device to a predicate device.
| Characteristic | Bio-Rad Lyphochek Coagulation Control (New Device) | Bio-Rad Lyphochek Coagulation Control (Substantially Equivalent Device) |
|---|---|---|
| Intended Use | A quality control plasma to monitor the precision of citrated coagulation systems. | A quality control plasma to monitor the precision of citrated coagulation systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human based control. | Human based control. |
| Storage | 2-8°C | 2-8°C |
| Open Vial Claim | 24 hours days when stored tightly capped at 2-25°C. | 24 hours days when stored tightly capped at 2-25°C. |
| Analytes | Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III), Thrombin Time (TT). | Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen. |
Device Performance Study (as implied by substantial equivalence):
The "study" implicitly referenced is a comparison of the new device's characteristics against those of a legally marketed predicate device (K964963). The new device adds more analytes (Antithrombin III and Thrombin Time) compared to the predicate, but otherwise maintains identical characteristics for the common analytes and other features, strongly suggesting comparable precision monitoring capabilities. No specific performance metrics (like coefficient of variation or bias data) are provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. This type of submission relies on demonstrating similarity in composition and manufacturing rather than extensive clinical performance data with a "test set" sample size in the traditional sense.
- Data Provenance: Not specified. It's a manufacturing and compositional comparison, not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of diagnostic accuracy (which would involve expert review) is not relevant for this coagulation control product's 510(k) submission.
4. Adjudication method for the test set
- Not Applicable. No test set or expert adjudication is described.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this submission is the characteristics and established performance of the predicate device, against which the new device is compared for substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is not a machine learning/AI device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. (See #8)
§ 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.