Food and Drug Administration, HHS § 862.3650

§ 862.3555 Lidocaine test system. § 862.3620 Methadone test system. (a) Identification. A lidocaine test sys- (a) Identification. A methadone test tem is a device intended to measure system is a device intended to measure lidocaine, an antiarrythmic and methadone, an addictive narcotic pain- anticonvulsant drug, in serum and relieving drug, in serum and urine. plasma. Measurements obtained by this Measurements obtained by this device device are used in the diagnosis and are used in the diagnosis and treat- treatment of lidocaine overdose or in ment of methadone use or overdose and monitoring levels of lidocaine to en- to determine compliance with regula- sure appropriate therapy. tions in methadone maintenance treat- (b) Classification. Class II. ment. (b) Classification. Class II. § 862.3560 Lithium test system. § 862.3630 Methaqualone test system. (a) Identification. A lithium test sys- (a) Identification. A methaqualone tem is a device intended to measure test system is a device intended to lithium (from the drug lithium car- measure methaqualone, a hypnotic and bonate) in serum or plasma. Measure- sedative drug, in urine. Measurements ments of lithium are used to assure obtained by this device are used in the that the proper drug dosage is adminis- diagnosis and treatment of methaqua- tered in the treatment of patients with lone use or overdose. mental disturbances, such as manic-de- (b) Classification. Class II. pressive illness (bipolar disorder). (b) Classification. Class II. § 862.3640 Morphine test system. (a) Identification. A morphine test § 862.3580 Lysergic acid diethylamide system is a device intended to measure (LSD) test system. morphine, an addictive narcotic pain- (a) Identification. A lysergic acid relieving drug, and its analogs in diethylamide (LSD) test system is a serum, urine, and gastric contents. device intended to measure lysergic Measurements obtained by this device acid diethylamide, a hallucinogenic are used in the diagnosis and treat- drug, in serum, urine, and gastric con- ment of morphine use or overdose and tents. Measurements obtained by this in monitoring levels of morphine and device are used in the diagnosis and its analogs to ensure appropriate ther- treatment of LSD use or overdose. apy. (b) Classification. Class II. (b) Classification. Class II.

§ 862.3600 Mercury test system. § 862.3645 Neuroleptic drugs radioreceptor assay test system. (a) Identification. A mercury test sys- (a) Identification. A neuroleptic drugs tem is a device intended to measure radioceptor assay test system is a de- mercury, a heavy metal, in human vice intended to measure in serum or specimens. Measurements obtained by plasma the dopamine receptor blocking this device are used in the diagnosis activity of neuroleptic drugs and their and treatment of mercury poisoning. active metabolites. A neuroleptic drug (b) Classification. Class I. has anti-psychotic action affecting principally psychomotor activity, is § 862.3610 Methamphetamine test sys- generally without hypnotic effects, and tem. is a tranquilizer. Measurements ob- (a) Identification. A methamphet- tained by this device are used to aid in amine test system is a device intended determining whether a patient is tak- to measure methamphetamine, a cen- ing the prescribed dosage level of such tral nervous system stimulating drug, drugs. in serum, plasma, and urine. Measure- (b) Classification. Class II. ments obtained by this device are used in the diagnosis and treatment of § 862.3650 Opiate test system. methamphetamine use or overdose. (a) Identification. An opiate test sys- (b) Classification. Class II. tem is a device intended to measure

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any of the addictive narcotic pain-re- ment of propoxyphene use or overdose lieving opiate drugs in blood, serum, or in monitoring levels of urine, gastric contents, and saliva. An propoxyphene to ensure appropriate opiate is any natural or synthetic drug therapy. that has morphine-like (b) Classification. Class II. pharmocological actions. The opiates include drugs such as morphine, mor- § 862.3750 Quinine test system. phine glucoronide, heroin, codeine, (a) Identification. A quinine test sys- nalorphine, and meperedine. Measure- tem is a device intended to measure ments obtained by this device are used quinine, a fever-reducing and pain-re- in the diagnosis and treatment of opi- lieving drug intended in the treatment ate use or overdose and in monitoring of malaria, in serum and urine. Meas- the levels of opiate administration to urements obtained by this device are ensure appropriate therapy. used in the diagnosis and treatment of (b) Classification. Class II. quinine overdose and malaria. (b) Classification. Class I. § 862.3660 Phenobarbital test system. (a) Identification. A phenobarbitol [52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, test system is a device intended to 2000] measure phenobarbital, an antiepileptic and sedative-hypnotic § 862.3830 Salicylate test system. drug, in human specimens. Measure- (a) Identification. A salicylate test ments obtained by this device are used system is a device intended to measure in the diagnosis and treatment of phe- salicylates, a class of analgesic, anti- nobarbital use or overdose and in moni- pyretic and anti-inflammatory drugs toring levels of phenobarbital to ensure that includes aspirin, in human speci- appropriate therapy. mens. Measurements obtained by this (b) Classification. Class II. device are used in diagnosis and treat- § 862.3670 Phenothiazine test system. ment of salicylate overdose and in monitoring salicylate levels to ensure (a) Identification. A phenothiazine appropriate therapy. test system is a device intended to (b) Classification. Class II. measure any of the drugs of the phenothiazine class in human speci- § 862.3840 Sirolimus test system. mens. Measurements obtained by this (a) Identification. A sirolimus test device are used in the diagnosis and system is a device intended to quan- treatment of phenothiazine use or titatively determine sirolimus con- overdose. centrations in whole blood. Measure- (b) Classification. Class II. ments are used as an aid in manage- § 862.3680 Primidone test system. ment of transplant patients receiving therapy with sirolimus. (a) Identification. A primidone test (b) Classification. Class II (special system is a device intended to measure controls). The special control is FDA’s primidone, an antiepileptic drug, in guidance document entitled ‘‘Class II human specimens. Measurements ob- Special Controls Guidance Document: tained by this device are used in the di- Sirolimus Test Systems.’’ See § 862.1(d) agnosis and treatment of primidone for the availability of this guidance overdose and in monitoring levels of document. primidone to ensure appropriate ther- apy. [69 FR 58259, Sept. 30, 2004] (b) Classification. Class II. § 862.3850 Sulfonamide test system. § 862.3700 Propoxyphene test system. (a) Identification. A sulfonamide test (a) Identification. A propoxyphene system is a device intended to measure test system is a device intended to sulfonamides, any of the antibacterial measure propoxyphene, a pain-reliev- drugs derived from sulfanilamide, in ing drug, in serum, plasma, and urine. human specimens. Measurements ob- Measurements obtained by this device tained by this device are used in the di- are used in the diagnosis and treat- agnosis and treatment of sulfonamide

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