FDA product code NOM: Antigen, Galactomannan, Aspergillus Spp.
NOM is the FDA product code for antigen, galactomannan, aspergillus spp.. It is a Class I device, regulated under 21 CFR 866.3040 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under NOM, 1 in the last five years, from 2 different applicants. The average 510(k) review took 234 days (median 220); 262 days on average over the last three years. FDA has posted 2 recalls for NOM devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Galactomannan, Aspergillus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3040 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NOM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 262 |
Compare with all 510(k) review times · Search every NOM clearance
Top NOM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 3 | 2011-01-13 |
| Pearl Diagnostics, Inc. | 1 | 2025-08-01 |
Most recent NOM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243496 | Pearl Diagnostics, Inc. | MycoMEIA Aspergillus Assay | 2025-08-01 | 262 |
| K093678 | Bio-Rad | PLATELIA ASPERGILLUS EIA MODEL 62793 | 2011-01-13 | 412 |
| K060641 | Bio-Rad | PLATELIA ASPERGILLUS EIA, MODEL 62793 | 2006-06-02 | 84 |
| K023857 | Bio-Rad | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 | 2003-05-16 | 177 |
Recalls for NOM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-01-25.
Frequently asked questions
What is FDA product code NOM?
NOM is the FDA product code for antigen, galactomannan, aspergillus spp.. It is a Class I device, regulated under 21 CFR 866.3040 and reviewed by the Microbiology panel.
What device class is NOM?
Class I, regulation 21 CFR 866.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOM?
Across 4 cleared submissions the average was 234 days from receipt to decision (median 220).
Which companies have the most NOM clearances?
Bio-Rad (3); Pearl Diagnostics, Inc. (1).
Have NOM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2005-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NOM
- Run a recall and safety report across every NOM manufacturer
- Watch product code NOM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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