862.1390 5-Hydroxyindole acetic acid/serotonin test system.§ 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
(a) Identification. A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.
(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.[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]