Food and Drug Administration, HHS § 862.1625 § 862.1595 Porphyrins test system. adrenal hyperplasia (congenital en- (a) Identification. A porphyrins test largement of the adrenal gland). system is a device intended to measure (b) Classification. Class I (general con- porphyrins (compounds formed during trols). The device is exempt from the the biosynthesis of heme, a constituent premarket notification procedures in of hemoglobin, and related compounds) subpart E of part 807 of this chapter in urine and feces. Measurements ob- subject to § 862.9. tained by this device are used in the di- [52 FR 16122, May 1, 1987, as amended at 65 agnosis and treatment of lead poi- FR 2308, Jan. 14, 2000] soning, porphyrias (primarily inherited diseases associated with disturbed por- § 862.1615 Pregnenolone test system. phyrin metabolism), and other diseases (a) Identification. A pregnenolone test characterized by alterations in the system is a device intended to measure heme pathway. pregnenolone (a precursor in the bio- (b) Classification. Class I (general con- synthesis of the adrenal hormone trols). The device is exempt from the cortisol and adrenal androgen) in premarket notification procedures in serum and plasma. Measurements ob- subpart E of part 807 of this chapter tained by this device are used in the di- subject to § 862.9. agnosis and treatment of diseases of [52 FR 16122, May 1, 1987, as amended at 65 the adrenal cortex or the gonads. FR 2308, Jan. 14, 2000] (b) Classification. Class I (general con- trols). The device is exempt from the § 862.1600 Potassium test system. premarket notification procedures in (a) Identification. A potassium test subpart E of part 807 of this chapter system is a device intended to measure subject to § 862.9. potassium in serum, plasma, and urine. [52 FR 16122, May 1, 1987, as amended at 65 Measurements obtained by this device FR 2308, Jan. 14, 2000] are used to monitor electrolyte balance in the diagnosis and treatment of dis- § 862.1620 Progesterone test system. eases conditions characterized by low (a) Identification. A progesterone test or high blood potassium levels. system is a device intended to measure (b) Classification. Class II. progesterone (a female hormone) in serum and plasma. Measurements ob- § 862.1605 Pregnanediol test system. tained by this device are used in the di- (a) Identification. A pregnanediol test agnosis and treatment of disorders of system is a device intended to measure the ovaries or placenta. pregnanediol (a major urinary meta- (b) Classification. Class I (general con- bolic product of progesterone) in urine. trols). The device is exempt from the Measurements obtained by this device premarket notification procedures in are used in the diagnosis and treat- subpart E of part 807 of this chapter ment of disorders of the ovaries or pla- subject to § 862.9. centa. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] trols). The device is exempt from the premarket notification procedures in § 862.1625 Prolactin (lactogen) test sys- subpart E of part 807 of this chapter tem. subject to § 862.9. (a) Identification. A prolactin [52 FR 16122, May 1, 1987, as amended at 65 (lactogen) test system is a device in- FR 2308, Jan. 14, 2000] tended to measure the anterior pitui- tary polypeptide hormone prolactin in § 862.1610 Pregnanetriol test system. serum and plasma. Measurements ob- (a) Identification. A pregnanetriol test tained by this device are used in the di- system is a device intended to measure agnosis and treatment of disorders of pregnanetriol (a precursor in the bio- the anterior pituitary gland or of the synthesis of the adrenal hormone hypothalamus portion of the brain. cortisol) in urine. Measurements ob- (b) Classification. Class I (general con- tained by this device are used in the di- trols). The device is exempt from the agnosis and treatment of congenital premarket notification procedures in 211 VerDate Nov<24>2008 08:24 Apr 27, 2010 Jkt 220072 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Y:\SGML\220072.XXX 220072 erowe on DSK5CLS3C1PROD with CFR.