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The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma.

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Acceptance Criteria and Device Performance for FibroTek FIB

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo clinical performance criteria. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the requirement for the new device to demonstrate comparable performance. The study described is a comparison study against the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Photo-optical instrument: r² = 0.969, slope = 0.859
• Mechanical instrument: r² = 0.958, slope = 0.848
  (Tested on normal and abnormal patient plasma, and plasma samples from patients undergoing heparin therapy) |
  | Within-run precision (CV) comparable to predicate (reported

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