Title 21: Food and Drugs
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/ PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
/ Subpart C - Clinical Laboratory Instruments / § 862.2800 Refractometer for clinical use.
§ 862.2800 Refractometer for clinical use.
(a) Identification. A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.
(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 the limitations in § 862.9.