510(k) · Cleared
ClearedInfiniti System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AutoGenomics, Inc. · NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Cleared on Feb 7, 2007 after a 341-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 7, 2007
- Review
- 341 days
- Class
- Class II
- Product code
- NPQ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK060564 Infiniti SystemAutoGenomics, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK073014 Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008
- Descendant · 2 generations on · 3 of its ownK101683 Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010
- Descendant · 3 generations on · 1 of its ownK123891 Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK220026 Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK132978 Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008 · cites it directly4descendants
- K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010 · 2 generations on3descendants
- K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013 · 3 generations on1descendant
- K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023 · 4 generations on0descendants
- K132978Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060564 | Infiniti System | AutoGenomics, Inc. | 2007 | — |
| +1 | K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin | Autogenomics, Incorporated | 2008 | — |
| +2 | K101683 | Infiniti CYP2C19 Assay | Autogenomics, Incorporated | 2010 | — |
| +3 | K123891 | Spartan RX CYP2C19 Test System | Spartan Bioscience, Inc. | 2013 | — |
| +4 | K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023 | — |
| +1 | K132978 | Impact DX Factor V Leiden and Factor II Genotyping Test | Sequenom, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Roche Factor V Leiden Kit Named without a submission number | |
| * | — | Roche Factor II (Prothrombin) G20210A Named without a submission number | |
| * | — | Affymetrix GeneChip® Microarray Instrumentation System Named without a submission number |
What descends from it? (8)
4 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?
- Of its descendants, K073014 (Autogenomics, Incorporated, 2008) has gone furthest, with 4 descendants of its own.
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. 2007, 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 INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI System Assay for Factor II & Factor V is a…
Read the full statement (117 words)
The INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.
The INFINITI System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
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/K060564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060564: Infiniti System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060564
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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