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For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1).

Lactate Dehydrogenase-SL Assay

This document is a 510(k) clearance letter from the FDA for a medical device called "Lactate Dehydrogenase-SL Assay". It does not describe acceptance criteria, the results of a study to prove the device meets acceptance criteria, or any of the other specific details requested in the prompt.

The letter states that the FDA has reviewed the 510(k) notification and determined that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered safe and effective for its intended use based on its similarity to existing devices.

To provide the information requested in the prompt, a study report or a different section of the 510(k) submission that details the performance data would be needed. This document only provides the regulatory clearance.

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