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Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

Pacific Hemostasis Heparin Control Level 2 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

The provided K992279 510(k) Summary describes the "Heparin Control Plasma, Level 2" device. This is an in vitro diagnostic device, specifically a control plasma used for heparin assay procedures and monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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