21 CFR §862.1520

1. (a)Identification. A 5′-nucleotidase test system is a device intended to measure the activity of the enzyme 5′-nucleotidase in serum and plasma. Measurements of 5′-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.
2. (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.