(190 days)
IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.
IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.
This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
Here's a breakdown of the acceptance criteria and study information for the IL Test™ Liquid Antithrombin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (IL Test™ Antithrombin). The key performance metrics are method comparison (correlation with the predicate) and within-run precision.
| Metric | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (ACL 6000) | Reported Device Performance (ACL Futura) |
|---|---|---|---|
| Method Comparison | |||
| Slope (vs. Predicate) | Close to 1.00 | 0.99 | 1.01 |
| Correlation Coefficient (r) | Close to 1.00 (e.g., >0.95 or >0.98) | 0.995 | 0.994 |
| Within Run Precision | |||
| Normal Plasma % CV | Low (typically |
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).