510(k) Report

FDA product code · Microbiology

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

QGNClass II21 CFR 866.3230510(k) required2 decisions since 20190 recalls

2 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 27 days (half between 27 and 27). No recall names this code. The most-cited predicate is DEN180032, named by 2 later devices.

A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in…

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 QGN 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 · QGN

1in 2021

2019: 12021: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QGN

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

Recalls per year · QGN

No recall names QGN since 2007.

Adverse event reports per year · QGN

No MAUDE report names QGN since 2007.

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
20191—00
20200—00
20211—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QGN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QGN? 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 QGN devices cite most?

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

  • DEN180032Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test)…Cd Diagnostics, Inc. · 20192cite it

Which QGN devices have the deepest lineage?

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

  • K212204Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5…Cd Diagnostics, Inc. · 20211generation

What has FDA decided in QGN lately?

  • K212204Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5…Cd Diagnostics, Inc. · 2021
  • DEN180032Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test)…Cd Diagnostics, Inc. · 2019

All 2 QGN decisions →

Related product codes

Other codes under 21 CFR 866.3230.

QXA Lateral Flow Immunochromatography Assay For…