(88 days)
The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
- The monitoring of heparin therapy.
- The monitoring of fibrinolysis therapy.
- The screening of disorders of fibrin formation.
- The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).
The provided document is a 510(k) summary for the BC Thrombin Reagent. This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive acceptance criteria and a standalone study for novel device performance. However, I can extract the relevant information from the "Comparative Analysis" and "Precision" sections to address your request as much as possible within the context of this submission.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (BC Thrombin Reagent vs. Predicate) |
|---|---|---|
| Correlation | High correlation with predicate device | Correlation coefficient: 0.93 |
| Agreement (Slope) | Slope close to 1.0 (indicating proportional agreement) | Slope: 1.48 |
| Agreement (Y-intercept) | Y-intercept close to 0 (indicating absence of systematic bias) | Y-intercept: -5.5 |
| Precision (Within-run) | Low variability (e.g., |
§ 864.7875 Thrombin time test.
(a)
Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.(b)
Classification. Class II (performance standards).