21 CFR §862.1195

1. (a)Identification. A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and p lasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands, especially those associated with hypertension and electrolyte disturbances.
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.