# K970510: Innoflour Topiramate Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Oxis Intl., Inc.
- Decided: May 12, 1997 after 90 days
- Product code: MSL (System, Test, Topiramatee)
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) INNOFLUOR™ Phenobarbital Assay System (INNOFLUOR™ Phenobarbital Reagent Set and INNOFLUOR™ Phenobarbital Calibrator Set): named in the summary without a submission number
- (no number) Abbott Phenobarbital II Assay: named in the summary without a submission number
- (no number) Topiramate Gas Chromatography: named in the summary without a submission number

## Most influential descendants
- K070645: Seradyn QMS Topiramate (2007), 6 descendants of its own
- K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00 (2009), 5 descendants of its own
- K091653: Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00 (2009), 1 descendant of its own
- K232522: ARK Levetiracetam II Assay (2024), 0 descendants of its own
- K201089: ARK Lacosamide Assay (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K970510
Methodology: https://510kreport.com/methodology