OHQ · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1660
Classification
FDA Product Code
OHQ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.1660
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.