510(k) · Cleared
ClearedIllumina Verncode Genotyping Test for Facor V and Factor II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Illumina, Inc. · NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
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
- NPQ
- 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 deviceK093129 Illumina Verncode Genotyping Test for Facor V and Factor IIIllumina, 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) | K093129 | Illumina Verncode Genotyping Test for Facor V and Factor II | 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 NPQ? 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 2…J. Substantial Equivalence Information: 1. Predicate device name(s): AutoGenomics INFINITI System for Factor II and Factor V 2. Predicate K number(s): k060564 3. Comparison with predicate: Similarities Item… | 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 NPQ devicesNPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NPQ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NPQ
Too few NPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NPQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPQ
2in 2017
MAUDE reports naming product code NPQ, 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 | — | 1 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 2 | — | 1 | 2 |
| 2011 | 1 | — | 1 | 15 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VeraCode Genotyping Test for Factor V and Factor II is an in vitro diagnostic device for the detection and genotyping of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTA-anticoagulated human blood samples. The test is intended for use on the BeadXpress System. The VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093129: Illumina Verncode Genotyping Test for Facor V and Factor II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093129
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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