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The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is used to verify the performance of the ACT instrument and the Heparinase (HR-HTC) cartridges. For In Vitro Diagnostic Use.

The modification to the current control is to replace old USP heparin with revised USP heparin. The source of the heparin remains porcine.

The provided text does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study with performance data against such criteria.

The document is a 510(k) summary for a device modification (CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control). It states that the modification is to replace old USP heparin with revised USP heparin, and that the device still has the "Same intended use," "Same operating principle," "Same technological characteristics," and "Same performance claims" as the predicate device (K042175).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, or training set information.

The document's conclusion simply states that the modified device is "substantially equivalent" to the predicate device because the fundamental scientific technology and intended use are unchanged. This suggests that extensive new performance studies to establish new acceptance criteria were likely not conducted or required for this type of 510(k) submission, as substantial equivalence to a previously cleared device implies that the new device meets the performance characteristics demonstrated by the predicate.

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