§ 862.1530. Plasma oncometry test system.
116 words·~1 min read·
/us/cfr/t21/s§ 862.1530·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A plasma oncometry test system is a device intended to measure plasma oncotic pressure. Plasma oncotic pressure is that portion of the total fluid pressure contributed by proteins and other molecules too large to pass through a specified membrane. Measurements of plasma oncotic pressure are used in the diagnosis and treatment of dehydration and circulatory disorders related to low serum protein levels and increased capillary permeability, such as edema and shock.
(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 2307, Jan. 14, 2000]