510(k) Report

FDA product code · Microbiology

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

QWRClass II21 CFR 866.3982510(k) required3 decisions since 20230 recalls

3 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 353 days (half between 259 and 379). No recall names this code. The most-cited predicate is K221925, named by 2 later devices.

A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another…

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 QWR 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 · QWR

1in 2025

2023: 22025: 1
2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QWR

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

Recalls per year · QWR

No recall names QWR since 2007.

Adverse event reports per year · QWR

25in 2025

2023: 122024: 902025: 25
2007high 90 (2024) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20232—012
20240—090
20251—025
20260—0—
FIG. 1 — QWR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QWR? 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

Which predicates do QWR devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K221925ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 20232cite it
  • K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 20231cites it

Which QWR devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc. · 20253generations
  • K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 20232generations
  • K221925ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 20231generation

What has FDA decided in QWR lately?

  • K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc. · 2025
  • K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023
  • K221925ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 20232 recalls

All 3 QWR decisions →

Related product codes

Other codes under 21 CFR 866.3982.

QVF Simple Point-Of-Care Device To Directly Detect…