OHQ — Multi-Analyte Controls Unassayed Class I
FDA product code OHQ covers "Multi-Analyte Controls Unassayed", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- OHQ
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.