510(k) · Cleared
ClearedIllumina Beadxpress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Illumina, Inc. · NSU Instrumentation For Clinical Multiplex Test Systems
Cleared on Apr 28, 2010 as substantially equivalent to K060564 (AutoGenomics, Inc., 2007) after a 208-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Apr 28, 2010
- Review
- 208 days
- Class
- Class II
- Product code
- NSU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060564 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK060564 Infiniti SystemAutoGenomics, Inc. · 2007
- This deviceK093128 Illumina Beadxpress SystemIllumina, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060564 | Infiniti System | AutoGenomics, Inc. | 2007 | — |
| 0 (this device) | K093128 | Illumina Beadxpress System | Illumina, Inc. | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NSU? 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 |
|---|---|---|---|
| * | K060564 | Infiniti SystemSummary page 4…cription use only with separately cleared VeraCode genotyping tests. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: k060564, INFINITI System for Factor II and Factor V 2. Comparison with Predicate Device:… | 2007 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K060564.
How does its category compare?
All NSU devicesNSU Instrumentation For Clinical Multiplex Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NSU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NSU
77in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NSU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NSU
18in 2025
MAUDE reports naming product code NSU, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 85 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 3 | 77 | 0 | 30 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 4 | 3 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 24 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BeadXpress® System is an in vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology. The BeadXpress System consists of the BeadXpress Reader and VeraScan software.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093128: Illumina Beadxpress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093128
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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