# Multi-Analyte Controls Unassayed
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 58
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OHQ)
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