510(k) · Cleared
ClearedMycoMEIA Aspergillus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pearl Diagnostics, Inc. · NOM Antigen, Galactomannan, Aspergillus Spp.
Cleared on Aug 1, 2025 as substantially equivalent to K093678 (Bio-Rad, 2011) after a 262-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Aug 1, 2025
- Review
- 262 days
- Class
- Class I
- Product code
- NOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K023857 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK023857 Platelia Aspergillus Eia, Models 62793 and 62794Bio-Rad · 2003 · Recalled
- 2 generations backK060641 Platelia Aspergillus Eia, Model 62793Bio-Rad · 2006
- 1 generation backK093678 Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
- This deviceK243496 MycoMEIA Aspergillus AssayPearl Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023857 | Platelia Aspergillus Eia, Models 62793 and 62794 | Bio-Rad | 2003 | 1 |
| −2 | K060641 | Platelia Aspergillus Eia, Model 62793 | Bio-Rad | 2006 | — |
| −1 | K093678 | Platelia Aspergillus Eia Model 62793 | Bio-Rad | 2011 | — |
| 0 (this device) | K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NOM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093678 | Platelia Aspergillus Eia Model 62793Summary page 5…ctomannan, Aspergillus Spp. Regulation Number: 866.3040 Product Code(s): NOM Predicate Trade Name: Bio-Rad Laboratories Platelia™ Aspergillus EIA Predicate 510(k) #: K093678 Predicate Product Code: NOM Device Description Summary: The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immuno… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All NOM devicesNOM Antigen, Galactomannan, Aspergillus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NOM
1in 2025
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
MAUDE reports naming product code NOM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MycoMEIA Aspergillus Assay (MycoMEIA) is an enzyme immunoassay (EIA) for the in vitro qualitative detection of Aspergillus antigens in human urine from adults (>/= 18 years old) with suspected invasive aspergillosis (IA). The assay is not intended for use in lung transplant recipients. The results should be interpreted by trained healthcare professionals, incorporating other diagnostic procedures such as microbiological culture, histological examination of biopsy samples, and radiographic evidence to support the diagnosis of IA.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243496: MycoMEIA Aspergillus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243496
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026