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For determining in vitro individual responses to heparinization using whole blood on the HMS Plus instrument. For in Vitro Diagnostic Use.

The modification to the current device is to replace old USP heparin with revised USP heparin. The heparin concentrations have been increased by 13.6% for heparinized channels (ch 1 & 2 and ch 3 &4). The source of the heparin remains porcine.

This document is a 510(k) summary for a modified Heparin Dose Response (HDR) Cartridge. It serves as a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The core modification is the replacement of old USP heparin with revised USP heparin, with increased concentrations in specific channels. The document establishes that the "intended use," "operating principle," "technological characteristics," and "performance claims" remain the same as the predicate device.

It contains no information about the acceptance criteria or a study proving the device meets those criteria, as it's a submission for a minor modification rather than a new device or a clinical performance study. Therefore, I cannot generate the requested table and answer to the specific questions regarding acceptance criteria and study details.

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