Search Results

cryocheck™ Clot S™ is a clot-based assay intended for the quantitative determination of protein S activity in citrated human plasma.

cryocheck™ Clot S™ is used to diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism. A deficiency in protein S may produce recurrent thrombotic episodes.

Congenital deficiencies of protein S are classified as three types:

• type I deficiencies correspond to reduced antigen levels of both total and free protein S .
• type II deficiencies are characterized by a reduced protein S activity but with normal . antigen levels of both total and free protein S
• type III deficiencies are defined by a reduced antigen level and activity of free protein S . but the antigen level of total protein S remains normal

Acquired protein S deficiencies are associated with several clinical states:

• oral anticoagulant therapy ●
• liver disease .
• disseminated intravascular coagulation .
• . oral contraceptives
• oestrogen therapy .
• acute phase inflammatory responses .
• pregnancy .
• newborns

CRYOcheck™ Clot S™ consists of:
• Protein S Deficient Plasma - contains citrated pooled normal
human plasma that has been depleted of protein S by
immunoadsorption, buffers and stabilizers.
• Clot S Activator - contains activated protein C, Russell's viper
venom, heparin neutralizing agents, buffers and stabilizers.
• Precision BioLogic Clot C & S Diluent (available separately from
Precision BioLogic).

Here's an analysis of the provided information regarding the acceptance criteria and study for the CRYOcheck™ Clot S™ device:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria for the new device's performance in isolation. Instead, the "performance" presented is the correlation to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 115 clinical samples.
• Data Provenance: The samples were "clinical samples from the target population for the assay." The document does not specify the country of origin, whether they were retrospective or prospective, or other explicit demographic details.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The "ground truth" in this context is established by the predicate device (STA® - Staclot® Protein S) rather than human experts interpreting results. The comparison is between the new device's measurements and the predicate device's measurements on the same samples.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication as the comparison was made against a predicate device's quantitative outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of how much Human Readers Improve with AI vs. without AI Assistance

Not applicable. This is a medical device for quantitative laboratory analysis, not an AI-based diagnostic tool requiring human reader interpretation in an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not explicitly stated as a "standalone" study in the AI sense, but the device performance itself, i.e., the quantitative measurement of protein S activity, is a standalone function. The "study" presented here is the comparison of this standalone function's output to that of a predicate device. The 0.880 correlation is a standalone performance metric relative to the predicate.

7. The Type of Ground Truth Used

The "ground truth" for the comparison study was the measurements obtained from the predicate device (STA® - Staclot® Protein S).

8. The Sample Size for the Training Set

Not applicable. This device is a biochemical assay, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device