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 Jan 13, 2011 as substantially equivalent to K060641 (Bio-Rad, 2006) after a 412-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Jan 13, 2011
- Review
- 412 days
- Class
- Class I
- Product code
- NOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023857 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK023857 Platelia Aspergillus Eia, Models 62793 and 62794Bio-Rad · 2003 · Recalled
- 1 generation backK060641 Platelia Aspergillus Eia, Model 62793Bio-Rad · 2006
- This deviceK093678 Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
- Descendant · cites it directly · 0 of its ownK243496 MycoMEIA Aspergillus AssayPearl Diagnostics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023857 | Platelia Aspergillus Eia, Models 62793 and 62794 | Bio-Rad | 2003 | 1 |
| −1 | K060641 | Platelia Aspergillus Eia, Model 62793 | Bio-Rad | 2006 | — |
| 0 (this device) | K093678 | Platelia Aspergillus Eia Model 62793 | Bio-Rad | 2011 | — |
| +1 | K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K060641 | Platelia Aspergillus Eia, Model 62793Summary page 3…L CHARACTERISTICS The following tables summarize similarities and differences between the PlateliaTM Aspergillus ELA (62793) and the current PlateliaTM Aspergillus ELA (k06064 1): Table ](a) Similarities between intended use Similarities in PlateliaT m Aspergillus EIA, PlateliaT m Aspergiil… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243496 | MycoMEIA Aspergillus Assay | 2025 | 0 |
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 8 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K243496 (Pearl Diagnostics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060641.
How does its category compare?
All NOM devicesNOM Antigen, Galactomannan, Aspergillus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar lavage (BAL) fluid samples.
The Platelia 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/K093678 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093678: Platelia Aspergillus Eia Model 62793.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093678
Report an extraction error
Are you the manufacturer?
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