510(k) · Cleared
ClearedInvader UGT1A1 Molecular Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Third Wave Technologies, Inc. · NTI Drug Metabolizing Enzyme Genotyping Systems
Cleared on Aug 18, 2005 as substantially equivalent to K043576 (Roche Molecular Systems, Inc., 2005) after a 44-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Aug 18, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- NTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN040011 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- 1 generation backK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- This deviceK051824 Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK070804 Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK073071 EQ-PRC LC Warfarin Genotyping KitTrimgen Corporation · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| −1 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| 0 (this device) | K051824 | Invader UGT1A1 Molecular Assay | Third Wave Technologies, Inc. | 2005 | — |
| +1 | K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test | Nanosphere, Inc. | 2007 | 1 |
| +2 | K073071 | EQ-PRC LC Warfarin Genotyping Kit | Trimgen Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K043576 | Roche Amplichip CYP450 TestSummary page 3…ARKETED DEVICE TO WHICH IS CLAIMED EQUIVALENCE The Invader® UGTIAI Molecular Assay is equivalent to the AmpliChip CYP450 Test for CYP2C 19 (510(k) Premarket Notification K043576, submitted December 03, 2004. 4. DESCRIPTION OF THE DEVICE The Invader® UGTIAI Molecular Assay is an in vitro diagnostic test… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test | 2007 | 1 |
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 1 year and passes through 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K070804 (Nanosphere, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K043576.
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 | — |
What is it indicated for?
The Invader® UGT1A1 Molecular Assay is an in vitro diagnostic test for the detection and genotyping of the *1 (TA6) and *28 (TA7) alleles of the UDP glucuronosyltransferase 1A1 (UGT1A1) gene in genomic DNA from whole peripheral blood as an aid in the identification of patients with greater risk for decreased UDP-glucuronosyltransferase activity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051824: Invader UGT1A1 Molecular Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051824
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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