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For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.

The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Chrono-log Model 700 Whole Blood Lumi-Aggregometer:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than establishing explicit acceptance criteria with pre-defined thresholds for performance. The "acceptance criteria" here are implicitly linked to achieving a high correlation with the predicate devices, indicating comparable performance.

Here's a table summarizing the reported device performance, with the understanding that the "acceptance criteria" were met by demonstrating strong correlation:

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