510(k) Report

FDA product code · Microbiology

Antigen, Latex Agglutination, T. Cruzi

GNEClass I21 CFR 866.3870510(k) required1 decision since 19840 recalls

1 FDA decision since 1984. No recall names this code.

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 GNE 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 · GNE

FDA has decided no GNE device since 2007.

Median 510(k) review, days · GNE

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

Recalls per year · GNE

No recall names GNE since 2007.

Adverse event reports per year · GNE

No MAUDE report names GNE 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
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — GNE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GNE? 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

What has FDA decided in GNE lately?

  • K834328Dat Test for Chagas' DiseaseSero-Immuno Diagnostics, Inc. · 1984

The one GNE decision →

Related product codes

Other codes under 21 CFR 866.3870.

GND Antigen, Iha, T. CruziLOO Reagent, Leishmanii SerologicalMIV Immunofluorescent Assay, T. CruziPIT Leishmania Spp. Antigen Detection AssayGNF Antigen, Cf, T. CruziOUZ Nucleic Amplification Assays For The Detection…MIU Enzyme Linked Immunosorbent Assay, T. Cruzi