FDA product code

Quality Control Material, Genetics, Rna

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

QIGClass II21 CFR 866.5910510(k) exempt0 decisions0 recalls

FDA lists QIG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based 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, device panel

Twenty years of QIG 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 · QIG

FDA has decided no QIG device since 2007.

Median 510(k) review, days · QIG

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

Recalls per year · QIG

No recall names QIG since 2007.

Adverse event reports per year · QIG

1in 2025

2007high 1 (2025) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in QIG? 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 866.5910.

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