510(k) · Cleared
ClearedInfiniti CYP2C19 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Autogenomics, Incorporated · NTI Drug Metabolizing Enzyme Genotyping Systems
Cleared on Oct 25, 2010 as substantially equivalent to K073014 (Autogenomics, Incorporated, 2008) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 2004. 3 later devices descend from it.
- Decided
- Oct 25, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- NTI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN040011 (2004). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- 2 generations backK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- 1 generation backK073014 Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008
- This deviceK101683 Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010
- Descendant · cites it directly · 1 of its ownK123891 Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK220026 Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK120466 Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc. · 2012 · Recalled
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 |
|---|---|---|---|---|---|
| −3 | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| −2 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| −1 | K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin | Autogenomics, Incorporated | 2008 | — |
| 0 (this device) | K101683 | Infiniti CYP2C19 Assay | Autogenomics, Incorporated | 2010 | — |
| +1 | K123891 | Spartan RX CYP2C19 Test System | Spartan Bioscience, Inc. | 2013 | — |
| +2 | K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023 | — |
| +1 | K120466 | Verigene CYP2C19 Nucleic Acid Tes (2C19) | Nanosphere, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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 NTI? 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 NTI device
- #1 K220026 Genomadix Cube CYP2C19 Systemscore 6.2 · 5 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinSummary page 1…g Enzyme Genotyping System NSU Instrumentation for Clinical Multiplex Test Systems Predicate Device (a) INFINITI Warfarin Assay (k0730 14) (b) AmpliChip CYP450 Microarray (k043576) Device Description The INFINITI CYP2CI9 Assay is an in vitro d… | 2008 |
| * | K043576 | Roche Amplichip CYP450 TestSummary page 1…SU Instrumentation for Clinical Multiplex Test Systems Predicate Device (a) INFINITI Warfarin Assay (k0730 14) (b) AmpliChip CYP450 Microarray (k043576) Device Description The INFINITI CYP2CI9 Assay is an in vitro diagnostic device which utilizes proprietary… | 2005 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K123891 (Spartan Bioscience, Inc., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NTI devicesNTI Drug Metabolizing Enzyme Genotyping Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NTI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NTI
116in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NTI
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NTI
2in 2011
MAUDE reports naming product code NTI, 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 | — | 2 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 116 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INFINITI CYP2Cl 9 Assay is an in vitro diagnostic test for the
identification of a patient's CYP45O 2C09 genotype in genomic
deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated
whole blood samples. The INFINITI CYP2CI 9 Assay is a
qualitative assay for use in clinical laboratories upon prescription
by the attending physician.
The INFINITI CYP2Cl 9 Assay is indicated for use as an aid to
clinicians in determining therapeutic strategy for therapeutics that
are metabolized by the CYP45O 2C1 9 gene product, specifically
*2, *3, *17.
The INFINITI CYP2Cl9 Assay is not indicated to be used to
predict drug response or non-response.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101683: Infiniti CYP2C19 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101683
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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