De Novo · Granted
GrantedAmplichip CYP450 Test, Model 04381866190
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · NTI Drug Metabolizing Enzyme Genotyping Systems
Granted on Dec 23, 2004 as a new device type through De Novo after a 3-day review. 10 later devices descend from it.
- Decided
- Dec 23, 2004
- Review
- 3 days
- Class
- Class II
- Product code
- NTI
- Recalls
- None
10 later devices descend from it, 2 citing it directly.
- This deviceDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 2 of its ownK051824 Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK123891 Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K043576Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · cites it directly8descendants
- K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008 · 2 generations on4descendants
- K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010 · 2 generations on3descendants
- K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005 · 2 generations on2descendants
- K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| +1 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| +2 | K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin | Autogenomics, Incorporated | 2008 | — |
| +2 | K101683 | Infiniti CYP2C19 Assay | Autogenomics, Incorporated | 2010 | — |
| +2 | K051824 | Invader UGT1A1 Molecular Assay | Third Wave Technologies, Inc. | 2005 | — |
| +3 | K123891 | Spartan RX CYP2C19 Test System | Spartan Bioscience, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
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?
- Of its descendants, K043576 (Roche Molecular Systems, Inc., 2005) has gone furthest, with 8 descendants 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.
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 | — |
https://510kreport.com/device/DEN040011 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN040011: Amplichip CYP450 Test, Model 04381866190.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN040011
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026