(98 days)
ThromboTek PSe is intended for the quantitative determination of functional Protein S activity in human plasma.
ThromboTek PSe is intended for the quantitative determination of functional Protein S activity, such as when identifying inherited or acquired Protein S deficiency.
ThromboTek PSe is a tissue factor pathway based clotting assay. The assay activator is a lyophilized preparation incorporating rabbit thromboplastin, calcium, buffer, and stabilizers. The remaining components of the assay are lyophilized activated Protein C, lyophilized human plasma depleted of Protein S, Imidazole buffered saline for use as a plasma diluent, and deionized water containing a preservative for reconstitution of the lyophilized components.
Here's a summary of the acceptance criteria and study details for the ThromboTek PSe assay, based on the provided K082631 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Low %CV for both normal and abnormal plasma samples. | Normal Plasma: Repeatability 4.9% CV, Total 5.7% CV |
| Abnormal Plasma: Repeatability 7.8% CV, Total 9.2% CV | ||
| Linearity | Linear across the clinically relevant range. | Linear from 10% Protein S to 156% Protein S (maximum tested). |
| Analytical Sensitivity | Low limit of detection for Protein S activity. | 1% Protein S. |
| Interferences | Minimal impact from common interferants at specified concentrations (e.g., |
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).