21 CFR Ch. I (4–1–20 Edition) § 862.1542

§ 862.1542 21 CFR Ch. I (4–1–20 Edition)

subpart E of part 807 of this chapter acid) in serum, plasma, and urine. subject to § 862.9. Measurements of phenylalanine are used in the diagnosis and treatment of [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] congenital phenylketonuria which, if untreated, may cause mental retarda- § 862.1542 Oxalate test system. tion. (a) Identification. An oxalate test sys- (b) Classification. Class II. tem is a device intended to measure § 862.1560 Urinary phenylketones the concentration of oxalate in urine. (nonquantitative) test system. Measurements of oxalate are used to aid in the diagnosis or treatment of (a) Identification. A urinary urinary stones or certain other meta- phenylketones (nonquantitative) test bolic disorders. system is a device intended to identify (b) Classification. Class I (general con- phenylketones (such as phenylpyruvic trols). The device is exempt from the acid) in urine. The identification of premarket notification procedures in urinary phenylketones is used in the subpart E of part 807 of this chapter diagnosis and treatment of congenital subject to § 862.9. phenylketonuria which, if untreated, may cause mental retardation. [52 FR 16122, May 1, 1987, as amended at 65 (b) Classification. Class I (general con- FR 2307, Jan. 14, 2000] trols). The device is exempt from the § 862.1545 Parathyroid hormone test premarket notification procedures in system. subpart E of part 807 of this chapter subject to § 862.9. (a) Identification. A parathyroid hormone test system is a device intended [52 FR 16122, May 1, 1987, as amended at 65 to measure the levels of parathyroid FR 2307, Jan. 14, 2000] hormone in serum and plasma. Meas- urements of parathyroid hormone lev- § 862.1565 6-Phosphogluconate dehy- els are used in the differential diag- drogenase test system. nosis of hypercalcemia (abnormally (a) Identification. A 6- high levels of calcium in the blood) and phosphogluconate dehydrogenase test hypocalcemia (abnormally low levels of system is a device intended to measure calcium in the blood) resulting from the activity of the enzyme 6- disorders of calcium metabolism. phosphogluconate dehydrogenase (6 (b) Classification. Class II. PGD) in serum and erythrocytes. Meas- urements of 6-phosphogluconate dehy- § 862.1550 Urinary pH (nonquantita- drogenase are used in the diagnosis and tive) test system. treatment of certain liver diseases (a) Identification. A urinary pH (non- (such as hepatitis) and anemias. quantitative) test system is a device (b) Classification. Class I (general con- intended to estimate the pH of urine. trols). The device is exempt from the Estimations of pH are used to evaluate premarket notification procedures in the acidity or alkalinity of urine as it subpart E of part 807 of this chapter relates to numerous renal and meta- subject to the limitations in § 862.9. bolic disorders and in the monitoring of patients with certain diets. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 862.1570 Phosphohexose isomerase subpart E of part 807 of this chapter test system. subject to § 862.9. (a) Identification. A phosphohexose [52 FR 16122, May 1, 1987, as amended at 65 isomerase test system is a device in- FR 2307, Jan. 14, 2000] tended to measure the activity of the enzyme phosphohexose isomerase in § 862.1555 Phenylalanine test system. serum. Measurements of (a) Identification. A phenylalanine phosphohexose isomerase are used in test system is a device intended to the diagnosis and treatment of muscle measure free phenylalanine (an amino diseases such as muscular dystrophy,

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liver diseases such as hepatitis or cir- nancies involving fetal distress associ- rhosis, and metastatic carcinoma. ated with placental insufficiency. (b) Classification. Class I (general con- Measurements of HPL are also used in trols). The device is exempt from the pregnancies complicated by hyper- premarket notification procedures in tension, proteinuria, edema, post-ma- subpart E of part 807 of this chapter turity, placental insufficiency, or pos- subject to § 862.9. sible miscarriage. (b) Classification. Class II. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1590 Porphobilinogen test sys- § 862.1575 Phospholipid test system. tem. (a) Identification. A phospholipid test (a) Identification. A porphobilinogen system is a device intended to measure test system is a device intended to phospholipids in serum and plasma. measure porphobilinogen (one of the Measurements of phospholipids are derivatives of hemoglobin which can used in the diagnosis and treatment of make the urine a red color) in urine. disorders involving lipid (fat) metabo- Measurements obtained by this device lism. are used in the diagnosis and treat- (b) Classification. Class I (general con- ment of porphyrias (primarily inher- trols). The device is exempt from the ited diseases associated with disturbed premarket notification procedures in porphyrine metabolism), lead poi- subpart E of part 807 of this chapter soning, and other diseases character- subject to the limitations in § 862.9. ized by alterations in the heme pathway. [52 FR 16122, May 1, 1987, as amended at 53 (b) Classification. Class I (general con- FR 21449, June 8, 1988; 66 FR 38788, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter § 862.1580 Phosphorus (inorganic) test system. subject to § 862.9. (a) Identification. A phosphorus (inor- [52 FR 16122, May 1, 1987, as amended at 65 ganic) test system is a device intended FR 2307, Jan. 14, 2000] to measure inorganic phosphorus in serum, plasma, and urine. Measure- § 862.1595 Porphyrins test system. ments of phosphorus (inorganic) are (a) Identification. A porphyrins test used in the diagnosis and treatment of system is a device intended to measure various disorders, including parathy- porphyrins (compounds formed during roid gland and kidney diseases, and vi- the biosynthesis of heme, a constituent tamin D imbalance. of hemoglobin, and related compounds) (b) Classification. Class I (general con- in urine and feces. Measurements ob- trols). The device is exempt from the tained by this device are used in the di- premarket notification procedures in agnosis and treatment of lead poi- subpart E of part 807 of this chapter soning, porphyrias (primarily inherited subject to the limitations in § 862.9. diseases associated with disturbed por- phyrin metabolism), and other diseases [52 FR 16122, May 1, 1987, as amended at 84 characterized by alterations in the FR 71796, Dec. 30, 2019] heme pathway. § 862.1585 Human placental lactogen (b) Classification. Class I (general con- test system. trols). The device is exempt from the premarket notification procedures in (a) Identification. A human placental subpart E of part 807 of this chapter lactogen test system is a device in- subject to § 862.9. tended to measure the hormone human placental lactogen (HPL), (also known [52 FR 16122, May 1, 1987, as amended at 65 as human chorionic FR 2308, Jan. 14, 2000] somatomammotrophin (HCS)), in maternal serum and maternal plasma. § 862.1600 Potassium test system. Measurements of human placental (a) Identification. A potassium test lactogen are used in the diagnosis and system is a device intended to measure clinical management of high-risk preg- potassium in serum, plasma, and urine.

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