FDA product code · Clinical chemistry

Multi-Analyte Controls Unassayed

Name: FDA decisions, review times, recalls and adverse event reports for product code OHQ
Creator: 510(k) Report

OHQClass I21 CFR 862.1660510(k) exempt0 decisions17 recalls

FDA lists OHQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 17 recalls name this code, 0 of them Class I.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of OHQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OHQ

FDA has decided no OHQ device since 2007.

Median 510(k) review, days · OHQ

Too few OHQ 510(k)s in any year since 2007 to give a median.

Recalls per year · OHQ

2in 2025

2007high 5 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OHQ

2in 2022

2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code OHQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	1
2017	—	5	2
2018	—	0	1
2019	—	1	0
2020	—	0	0
2021	—	0	0
2022	—	5	2
2023	—	1	0
2024	—	0	0
2025	—	2	0
2026	—	3	—

FIG. 1 — OHQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OHQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.1660.

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Multi-Analyte Controls Unassayed

What has been recalled in OHQ lately?

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