510(k) · Cleared
ClearedInnoflour Topiramate Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxis Intl., Inc. · MSL System, Test, Topiramatee
Cleared on May 12, 1997 after a 90-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 12, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- MSL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK970510 Innoflour Topiramate Reagent SetOxis Intl., Inc. · 1997
- Descendant · cites it directly · 6 of its ownK070645 Seradyn QMS TopiramateSeradyn, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK083799 Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate…Ark Diagnostics, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK091653 Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark…Ark Diagnostics, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK232522 ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK201089 ARK Lacosamide AssayArk Diagnostics, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070645Seradyn QMS TopiramateSeradyn, Inc. · 2007 · cites it directly6descendants
- K083799Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Ark Diagnostics, Inc. · 2009 · 2 generations on5descendants
- K091653Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Ark Diagnostics, Inc. · 2009 · 3 generations on1descendant
- K232522ARK Levetiracetam II AssayArk Diagnostics, Inc. · 2024 · 4 generations on0descendants
- K201089ARK Lacosamide AssayArk Diagnostics, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970510 | Innoflour Topiramate Reagent Set | Oxis Intl., Inc. | 1997 | — |
| +1 | K070645 | Seradyn QMS Topiramate | Seradyn, Inc. | 2007 | — |
| +2 | K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… | Ark Diagnostics, Inc. | 2009 | — |
| +3 | K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam… | Ark Diagnostics, Inc. | 2009 | — |
| +4 | K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | 2024 | — |
| +3 | K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 MSL? 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 (INNOFLUOR™ Phenobarbital Reagent Set and… 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070645 | Seradyn QMS Topiramate | 2007 | 6 |
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, K070645 (Seradyn, Inc., 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MSL devicesMSL System, Test, Topiramatee: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSL
FDA has decided no MSL device since 2007.
Median 510(k) review, days · MSL
Too few MSL 510(k)s in any year since 2007 to give a median.
Recalls per year · MSL
No recall names MSL since 2007.
Adverse event reports per year · MSL
No MAUDE report names MSL 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 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 Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR™ Topiramate Control Set are packaged and sold separately; but are referred to collectively, in all associated product labeling, as the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quantitative determination of total topiramate in serum or heparinized plasma by fluorescence…
Read the full statement (260 words)
The INNOFLUOR™ Topiramate Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR™ Topiramate Control Set are packaged and sold separately; but are referred to collectively, in all associated product labeling, as the INNOFLUOR™ Topiramate Assay System.
The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quantitative determination of total topiramate in serum or heparinized plasma by fluorescence polarization immunoassay. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® (TDx/TDxFLx®) analyzer.
The INNOFLUOR™ Topiramate Reagent Set is intended for the quantitative determination of total topiramate in serum or heparinized plasma. The reagent set is intended for use in the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Calibrator Set is intended for use in the calibration of the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Reagent Set and Calibrator Set are used together to generate the calibration curve. The calibration curve must be established prior to assaying unknown samples. Prior to performing the calibration procedure, the correct analyzer operating parameters must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR™ Topiramate Reagent Set. The INNOFLUOR™ Topiramate Control Set is intended for use in the quality control of the INNOFLUOR™ Topiramate Assay System. The concentrations of the two levels of the controls have been selected to best monitor the quality and stability of the calibration curve. The control results must be within established acceptable ranges before patient samples are assayed.
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/K970510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970510: Innoflour Topiramate Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970510
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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