510(k) Report

FDA product code · Microbiology

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

QXAClass II21 CFR 866.3230510(k) required2 decisions since 20230 recalls

2 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 88 days (half between 88 and 88). No recall names this code. The most-cited predicate is K230917, named by 1 later device.

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 QXA 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 · QXA

1in 2023

2023: 12026 (partial year): 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXA

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

Recalls per year · QXA

No recall names QXA since 2007.

Adverse event reports per year · QXA

No MAUDE report names QXA 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
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20261—0—
FIG. 1 — QXA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QXA? 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 QXA devices cite most?

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

  • K230917FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 20231cites it

Which QXA devices have the deepest lineage?

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

  • K260787FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 20262generations
  • K230917FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 20231generation

What has FDA decided in QXA lately?

  • K260787FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 2026
  • K230917FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 2023

All 2 QXA decisions →

Related product codes

Other codes under 21 CFR 866.3230.

QGN Lateral Flow Immunochromatography Assay For…