510(k) · Cleared
ClearedPlatelia Aspergillus Eia, Model 62793
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · NOM Antigen, Galactomannan, Aspergillus Spp.
Cleared on Jun 2, 2006 as substantially equivalent to K023857 (Bio-Rad, 2003) after an 84-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 84 days
- Class
- Class I
- Product code
- NOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023857 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023857 Platelia Aspergillus Eia, Models 62793 and 62794Bio-Rad · 2003 · Recalled
- This deviceK060641 Platelia Aspergillus Eia, Model 62793Bio-Rad · 2006
- Descendant · cites it directly · 1 of its ownK093678 Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
- Descendant · 2 generations on · 0 of its ownK243496 MycoMEIA Aspergillus AssayPearl Diagnostics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK101407 Alpha Histoplasma Antigen Eia Model HAG102Immuno-Mycologics, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023857 | Platelia Aspergillus Eia, Models 62793 and 62794 | Bio-Rad | 2003 | 1 |
| 0 (this device) | K060641 | Platelia Aspergillus Eia, Model 62793 | Bio-Rad | 2006 | — |
| +1 | K093678 | Platelia Aspergillus Eia Model 62793 | Bio-Rad | 2011 | — |
| +2 | K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | 2025 | — |
| +1 | K101407 | Alpha Histoplasma Antigen Eia Model HAG102 | Immuno-Mycologics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2025 | 1 | 0 |
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.
Top candidate predicates for a new NOM device
- #1 K243496 MycoMEIA Aspergillus Assayscore 10.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K023857 | Platelia Aspergillus Eia, Models 62793 and 62794Summary page 2…CAL CHARACTERISTICS The following tables summarize similarities and differences between the Platelia TM Aspergillus EIA (Catalog #62793) and PlateliaTM Aspergillus EIA (k023857): Table 1(a) Similarities between intended use Similarities in PlateliaTM Aspergillus EIA, PlateliaTM Asper… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K093678 (Bio-Rad, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NOM devicesNOM Antigen, Galactomannan, Aspergillus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PlateliaTM Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum samples.
The PlateliaTM Aspergillus EIA 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060641: Platelia Aspergillus Eia, Model 62793.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060641
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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