OHQ

Multi-Analyte Controls Unassayed

Product code

OHQ

Device name

Multi-Analyte Controls Unassayed

Device class

Class 1

21 CFR

21 CFR 862.1660

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

FDA classification definition

A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.

Definition text from the FDA device classification database (U.S. federal government work, public domain).