FDA product code · Microbiology

Sars-Cov-2 Serology Test

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

QVPClass II21 CFR 866.3983510(k) required5 decisions since 20230 recalls

5 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 53 days (half between 34 and 71). No recall names this code. The most-cited predicate is DEN210040, named by 2 later devices.

A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.

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 QVP 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 · QVP

2in 2025

2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QVP

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

Recalls per year · QVP

No recall names QVP since 2007.

Adverse event reports per year · QVP

No MAUDE report names QVP since 2007.

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	0	—	0
2022	0	—	0
2023	2	—	0
2024	0	—	0
2025	2	—	0
2026	1	—	—

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

Planning a device in QVP? 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

Sars-Cov-2 Serology Test

Which predicates do QVP devices cite most?

Which QVP devices have the deepest lineage?

What has FDA decided in QVP lately?