FDA product code · Microbiology

Coronavirus Antigen Detection Test System.

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

QKPClass N0 decisions27 recalls

0 FDA decisions. 27 recalls name this code, 14 of them Class I.

The qualitative detection of coronavirus viral antigens directly from clinical specimens.

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 QKP 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 · QKP

FDA has decided no QKP device since 2007.

Median 510(k) review, days · QKP

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

Recalls per year · QKP

17in 2022

2007high 17 (2022) · low 0 (2007)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · QKP

744in 2025

2007high 13,075 (2022) · low 0 (2007)2025

MAUDE reports naming product code QKP, 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	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	1	1,372
2021	—	9 (4)	6,561
2022	—	17 (10)	13,075
2023	—	0	3,478
2024	—	0	1,406
2025	—	0	744
2026	—	0	—

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

Planning a device in QKP? 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

Coronavirus Antigen Detection Test System.

What has been recalled in QKP lately?