21 CFR 862.1530 — Membrane Osmometry, Plasma Oncometry

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1530

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.

Classification Rationale

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.

Product Codes