Food and Drug Administration, HHS § 862.1570

urinary stones or certain other meta- § 862.1560 Urinary phenylketones bolic disorders. (nonquantitative) test system. (b) Classification. Class I (general con- (a) Identification. A urinary trols). The device is exempt from the phenylketones (nonquantitative) test premarket notification procedures in system is a device intended to identify subpart E of part 807 of this chapter phenylketones (such as phenylpyruvic subject to § 862.9. acid) in urine. The identification of [52 FR 16122, May 1, 1987, as amended at 65 urinary phenylketones is used in the FR 2307, Jan. 14, 2000] diagnosis and treatment of congenital phenylketonuria which, if untreated, § 862.1545 Parathyroid hormone test may cause mental retardation. system. (b) Classification. Class I (general con- (a) Identification. A parathyroid hor- trols). The device is exempt from the mone test system is a device intended premarket notification procedures in to measure the levels of parathyroid subpart E of part 807 of this chapter hormone in serum and plasma. Meas- subject to § 862.9. urements of parathyroid hormone lev- [52 FR 16122, May 1, 1987, as amended at 65 els are used in the differential diag- FR 2307, Jan. 14, 2000] nosis of hypercalcemia (abnormally high levels of calcium in the blood) and § 862.1565 6-Phosphogluconate dehy- hypocalcemia (abnormally low levels of drogenase test system. calcium in the blood) resulting from (a) Identification. A 6- disorders of calcium metabolism. phosphogluconate dehydrogenase test (b) Classification. Class II. system is a device intended to measure the activity of the enzyme 6- § 862.1550 Urinary pH (nonquantita- tive) test system. phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. Meas- (a) Identification. A urinary pH (non- urements of 6-phosphogluconate dehy- quantitative) test system is a device drogenase are used in the diagnosis and intended to estimate the pH of urine. treatment of certain liver diseases Estimations of pH are used to evaluate (such as hepatitis) and anemias. the acidity or alkalinity of urine as it (b) Classification. Class I (general con- relates to numerous renal and meta- trols). The device is exempt from the bolic disorders and in the monitoring premarket notification procedures in of patients with certain diets. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 862.9. trols). The device is exempt from the premarket notification procedures in [52 FR 16122, May 1, 1987, as amended at 53 subpart E of part 807 of this chapter FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 § 862.1570 Phosphohexose isomerase FR 2307, Jan. 14, 2000] test system. (a) Identification. A phosphohexose § 862.1555 Phenylalanine test system. isomerase test system is a device in- (a) Identification. A phenylalanine tended to measure the activity of the test system is a device intended to enzyme phosphohexose isomerase in measure free phenylalanine (an amino serum. Measurements of acid) in serum, plasma, and urine. phosphohexose isomerase are used in Measurements of phenylalanine are the diagnosis and treatment of muscle used in the diagnosis and treatment of diseases such as muscular dystrophy, congenital phenylketonuria which, if liver diseases such as hepatitis or cir- untreated, may cause mental retarda- rhosis, and metastatic carcinoma. tion. (b) Classification. Class I (general con- (b) Classification. Class II. trols). The device is exempt from the premarket notification procedures in

241

VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00251 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150 § 862.1575 21 CFR Ch. I (4–1–14 Edition)

subpart E of part 807 of this chapter § 862.1590 Porphobilinogen test sys- subject to § 862.9. tem. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A porphobilinogen FR 2307, Jan. 14, 2000] test system is a device intended to measure porphobilinogen (one of the § 862.1575 Phospholipid test system. derivatives of hemoglobin which can (a) Identification. A phospholipid test make the urine a red color) in urine. system is a device intended to measure Measurements obtained by this device phospholipids in serum and plasma. are used in the diagnosis and treat- Measurements of phospholipids are ment of porphyrias (primarily inher- used in the diagnosis and treatment of ited diseases associated with disturbed disorders involving lipid (fat) metabo- porphyrine metabolism), lead poi- lism. soning, and other diseases character- (b) Classification. Class I (general con- ized by alterations in the heme path- trols). The device is exempt from the way. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 862.9. premarket notification procedures in subpart E of part 807 of this chapter [52 FR 16122, May 1, 1987, as amended at 53 subject to § 862.9. FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1580 Phosphorus (inorganic) test system. § 862.1595 Porphyrins test system. (a) Identification. A phosphorus (inor- (a) Identification. A porphyrins test ganic) test system is a device intended system is a device intended to measure to measure inorganic phosphorus in porphyrins (compounds formed during serum, plasma, and urine. Measure- the biosynthesis of heme, a constituent ments of phosphorus (inorganic) are of hemoglobin, and related compounds) used in the diagnosis and treatment of in urine and feces. Measurements ob- various disorders, including parathy- tained by this device are used in the di- roid gland and kidney diseases, and vi- agnosis and treatment of lead poi- tamin D imbalance. soning, porphyrias (primarily inherited (b) Classification. Class I. diseases associated with disturbed por- phyrin metabolism), and other diseases § 862.1585 Human placental lactogen characterized by alterations in the test system. heme pathway. (a) Identification. A human placental (b) Classification. Class I (general con- lactogen test system is a device in- trols). The device is exempt from the tended to measure the hormone human premarket notification procedures in placental lactogen (HPL), (also known subpart E of part 807 of this chapter as human chorionic subject to § 862.9. somatomammotrophin (HCS)), in ma- [52 FR 16122, May 1, 1987, as amended at 65 ternal serum and maternal plasma. FR 2308, Jan. 14, 2000] Measurements of human placental lactogen are used in the diagnosis and § 862.1600 Potassium test system. clinical management of high-risk preg- (a) Identification. A potassium test nancies involving fetal distress associ- system is a device intended to measure ated with placental insufficiency. potassium in serum, plasma, and urine. Measurements of HPL are also used in Measurements obtained by this device pregnancies complicated by hyper- are used to monitor electrolyte balance tension, proteinuria, edema, post-ma- in the diagnosis and treatment of dis- turity, placental insufficiency, or pos- eases conditions characterized by low sible miscarriage. or high blood potassium levels. (b) Classification. Class II. (b) Classification. Class II.

242

VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00252 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150