drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

(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 2309, Jan. 14, 2000]

§ 862.2900 Automated urinalysis system.

(a) Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

(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 2309, Jan. 14, 2000]

§ 862.2920 Plasma viscometer for clinical use.

(a) Identification. A plasma viscometer for clinical use is a device intended to measure the viscosity of plasma by determining the time period required for the plasma to flow a measured distance through a calibrated glass tube. Measurements obtained by this device are used to monitor changes in the amount of solids present in plasma in various disorders.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]

Subpart D-Clinical Toxicology Test Systems

§ 862.3030 Acetaminophen test system. (a) Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic

and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

(b) Classification. Class II.

§ 862.3035 Amikacin test system.

(a) Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3040 Alcohol test system.

(a) Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

(b) Classification. Class II.

§ 862.3050 Breath-alcohol test system.

(a) Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

(b) Classification. Class I.

§ 862.3100 Amphetamine test system.

(a) Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3110 Antimony test system.

(a) Identification. An antimony test system is a device intended to measure antimony, a heavy metal, in urine, blood, vomitus, and stomach contents. Measurements obtained by this device

are used in the diagnosis and treatment of antimony poisoning.

(b) Classification. Class I.

§ 862.3120 Arsenic test system.

(a) Identification. An arsenic test system is a device intended to measure arsenic, a poisonous heavy metal, in urine, vomitus, stomach contents, nails, hair, and blood. Measurements obtained by this device are used in the diagnosis and treatment of arsenic poisoning.

(b) Classification. Class I.

§ 862.3150 Barbiturate test system.

(a) Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3170 Benzodiazepine test system. (a) Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

flurazepam,

(b) Classification. Class II.

§ 862.3200 Clinical toxicology calibrator.

(a) Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also §862.2 in this part.)

§ 862.3240 Cholinesterase test system.

(a) Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning). (b) Classification. Class I.

§ 862.3250 Cocaine and cocaine metabolite test system.

(a) Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

(b) Classification. Class II.

§ 862.3270 Codeine test system.

(a) Identification. A codeine test system is a device intended to measure codeine (a narcotic pain-relieving drug) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of codeine use or overdose and in monitoring levels of codeine to ensure appropriate therapy. (b) Classification. Class II.

§ 862.3280 Clinical toxicology control material.

(a) Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

(b) Classification. Class I (general controls). Except when used in donor screening, unassayed material 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 2309, Jan. 14, 2000]

§ 862.3300 Digitoxin test system.

(a) Identification. A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3320 Digoxin test system.

(a) Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3350 Diphenylhydantoin test sys

tem.

(a) Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate

therapy.

(b) Classification. Class II.

§ 862.3380 Ethosuximide test system.

(a) Identification. An ethosuximide test system is a device intended to measure ethosuximide, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3450 Gentamicin test system.

(a) Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate ther

apy.

(b) Classification. Class II.

§ 862.3520 Kanamycin test system.

(a) Identification. A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy. (b) Classification. Class II.

§ 862.3550 Lead test system.

(a) Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

(b) Classification. Class II.

§ 862.3555 Lidocaine test system.

(a) Identification. A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3630 Methaqualone test system.

(a) Identification. A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.

(b) Classification. Class II.

§ 862.3640 Morphine test system.

(a) Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic painrelieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therару.

(b) Classification. Class II. §862.3645 Neuroleptic

drugs radioreceptor assay test system.

(a) Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

(b) Classification. Class II.

§ 862.3650 Opiate test system.

(a) Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3670 Phenothiazine test system. (a) Identification. A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine overdose.

(b) Classification. Class II.

use or

§862.3680 Primidone test system.

(a) Identification. A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3700 Propoxyphene test system. (a) Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose in monitoring levels propoxyphene to ensure appropriate therapy.

or

(b) Classification. Class II.

§ 862.3750 Quinine test system.

of

(a) Identification. A quinine test system is a device intended to measure quinine, a fever-reducing and pain-relieving drug intended in the treatment of malaria, in serum and urine. Measurements obtained by this device are

used in the diagnosis and treatment of quinine overdose and malaria.

(b) Classification. Class I.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, 2000]