FDA product code · Microbiology

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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

QQXClass II21 CFR 866.3981510(k) required11 decisions since 20210 recalls

11 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 203 days (half between 143 and 292). No recall names this code. The most-cited predicate is K211079, named by 7 later devices.

A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid…

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, microbiology panel

Twenty years of QQX 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 · QQX

3in 2025

2007high 3 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QQX

180in 2025

2007high 320 (2022) · low 180 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QQX

No recall names QQX since 2007.

Adverse event reports per year · QQX

1in 2022

2007high 1 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	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	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	3	320	1
2023	2	—	0
2024	2	—	0
2025	3	180	0
2026	0	—	—

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

Planning a device in QQX? 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

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Other codes under 21 CFR 866.3981.

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Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Which predicates do QQX devices cite most?

Which QQX devices have the deepest lineage?

What has FDA decided in QQX lately?

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