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The glocose hexokinase reagents are intended for Invitro diagnosti in the quantitative determination of glucose in serum, plasma ne and CSF

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This document is a 510(k) clearance letter for a "Glucose Hexokinase" device, which is a reagent intended for in vitro diagnostic use in the quantitative determination of glucose in serum, plasma, and CSF. This type of device is a laboratory reagent and not an AI/ML powered medical device. Therefore, the questions regarding acceptance criteria and study designs relevant to AI/ML devices, such as test set size, expert ground truth, adjudication methods, MRMC studies, and training set information, are not applicable to this document.

The letter confirms that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is the primary "acceptance criterion" for 510(k) clearance in this context, implying that the device performs comparably to devices already on the market. However, the specific performance data that led to this determination is not detailed in this clearance letter itself. Such data would typically be found in the sponsor's 510(k) submission, not the FDA's response letter.

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