510(k) Report

FDA product code · Microbiology

Antigen, Galactomannan, Aspergillus Spp.

NOMClass I21 CFR 866.3040510(k) required4 decisions since 20032 recalls

4 FDA decisions since 2003. 510(k) reviews decided 2021–2025 took a median of 262 days (half between 262 and 262). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K060641, named by 2 later devices.

The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

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 NOM 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 · NOM

1in 2025

2011: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NOM

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

Recalls per year · NOM

No recall names NOM since 2007.

Adverse event reports per year · NOM

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code NOM, 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
20111—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20260—0—
FIG. 1 — NOM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NOM? 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 NOM devices cite most?

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

  • K060641Platelia Aspergillus Eia, Model 62793Bio-Rad · 20062cite it
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 20111cites it
  • K023857Platelia Aspergillus Eia, Models 62793 and 62794Bio-Rad · 20031cites it

Which NOM devices have the deepest lineage?

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

  • K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc. · 20253generations
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 20112generations
  • K060641Platelia Aspergillus Eia, Model 62793Bio-Rad · 20061generation

What has FDA decided in NOM lately?

  • K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc. · 2025
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
  • K060641Platelia Aspergillus Eia, Model 62793Bio-Rad · 2006
  • K023857Platelia Aspergillus Eia, Models 62793 and 62794Bio-Rad · 20031 recall

All 4 NOM decisions →

What has been recalled in NOM lately?

  • K870176Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN…Bio Rad Laboratories, Inc. · Jan 25, 2005
  • K023857Platelia Aspergillus EIABio Rad Laboratories, Inc. · Nov 6, 2003

Related product codes

Other codes under 21 CFR 866.3040.

KFG Antiserum, Positive Control, Aspergillus Spp.JWT Antigen, Cf, Aspergillus Spp.