(a) Identification. A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large to pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are useful in the diagnosis and treatment of these disorders.

(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.