FDA product code OHQ: Multi-Analyte Controls Unassayed
OHQ is the FDA product code for multi-analyte controls unassayed. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. Devices under OHQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 24 recalls for OHQ devices, 15 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Multi-Analyte Controls Unassayed |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for OHQ devices
24 product recalls in 18 recall events; 15 initiated in the last five years and 9 still open. Most recent: 2025-10-17.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 7 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code OHQ?
OHQ is the FDA product code for multi-analyte controls unassayed. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is OHQ?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
Have OHQ devices been recalled?
Yes: 24 product recalls across 18 recall events; the most recent began 2025-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code OHQ
- Run a recall and safety report across every OHQ manufacturer
- Watch product code OHQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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