# K970509: Innoflour Calibrator Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Oxis Intl., Inc.
- Decided: May 12, 1997 after 90 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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

## Most influential descendants
- 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
- K153596: ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (2016), 0 descendants of its own

## Indications for use
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 TDxFLX® analyzer.

Source page: https://510kreport.com/device/K970509
Methodology: https://510kreport.com/methodology