510(k) · Cleared
ClearedInnofluor Topiramate Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxis Intl., Inc. · LAS Drug Specific Control Materials
Cleared on May 12, 1997 after a 90-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- May 12, 1997
- Review
- 90 days
- Class
- Class I
- Product code
- LAS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK970517 Innofluor Topiramate Control SetOxis Intl., Inc. · 1997
- Descendant · cites it directly · 5 of its ownK083799 Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate…Ark Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK091653 Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark…Ark Diagnostics, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK232522 ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK201089 ARK Lacosamide AssayArk Diagnostics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite…Ark Diagnostics, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083799Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Ark Diagnostics, Inc. · 2009 · cites it directly5descendants
- K091653Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Ark Diagnostics, Inc. · 2009 · 2 generations on1descendant
- K232522ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024 · 3 generations on0descendants
- K201089ARK Lacosamide AssayArk Diagnostics, Inc. · 2021 · 2 generations on0descendants
- K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970517 | Innofluor Topiramate Control Set | Oxis Intl., Inc. | 1997 | — |
| +1 | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | Ark Diagnostics, Inc. | 2009 | — |
| +2 | K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam… | Ark Diagnostics, Inc. | 2009 | — |
| +3 | K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | 2024 | — |
| +2 | K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021 | — |
| +2 | K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator… | Ark Diagnostics, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 LAS? 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 |
|---|---|---|---|
| * | — | INNOFLUOR™ Phenobarbital Assay System Named without a submission number | |
| * | — | Abbott Phenobarbital II Assay Named without a submission number | |
| * | — | Topiramate Gas Chromatography Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | 2009 | 5 |
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, K083799 (Ark Diagnostics, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LAS devicesLAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LAS
Too few LAS 510(k)s in any year since 2007 to give a median.
Recalls per year · LAS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAS
No MAUDE report names LAS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 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 INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plasma for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDXFL® analyzer
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/K970517 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970517: Innofluor Topiramate Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970517
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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