510(k) · Cleared
ClearedSpartan RX CYP2C19 Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spartan Bioscience, Inc. · NTI Drug Metabolizing Enzyme Genotyping Systems
Cleared on Aug 12, 2013 as substantially equivalent to K101683 (Autogenomics, Incorporated, 2010) after a 237-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Aug 12, 2013
- Review
- 237 days
- Class
- Class II
- Product code
- NTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN040011 (2004). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- 3 generations backK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- 2 generations backK073014 Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008
- 1 generation backK101683 Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010
- This deviceK123891 Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK220026 Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| −3 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| −2 | K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin | Autogenomics, Incorporated | 2008 | — |
| −1 | K101683 | Infiniti CYP2C19 Assay | Autogenomics, Incorporated | 2010 | — |
| 0 (this device) | K123891 | Spartan RX CYP2C19 Test System | Spartan Bioscience, Inc. | 2013 | — |
| +1 | K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K101683 | Infiniti CYP2C19 AssaySummary page 1…ystem NSU: Instrumentation for clinical multiplex test systems Predicate Device: INFINITI CYP2CIR Assay, 510(k) Number K(101683 Classification Code: NTI and NSU, Regulation No. 862.3360 and 8… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220026 | Genomadix Cube CYP2C19 System | 2023 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K220026 (Genomadix, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K101683.
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. 2013, 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?
Assay - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Assay will be run on the Spartan RX Platform from the buccal sample collected with a buccal swab. The Spartan RX CYP2C19 Assay is not indicated to be used to predict…
Read the full statement (142 words)
Assay - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Assay will be run on the Spartan RX Platform from the buccal sample collected with a buccal swab. The Spartan RX CYP2C19 Assay is not indicated to be used to predict drug response or non-response.
Platform - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Platform will be used to run the Spartan RX CYP2C19 Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123891 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123891: Spartan RX CYP2C19 Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123891
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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