# K972331: Innofluor Gentamicin Assay System

- Pathway: 510(k) (Traditional)
- Applicant: Oxis Intl., Inc.
- Decided: Aug 1, 1997 after 39 days
- Product code: LGQ (Fluorescence Polarization Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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® Gentamicin Assay System, Existing: named in the summary without a submission number
- (no number) Abbott Gentamicin Assay: named in the summary without a submission number

## Indications for use
The INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set are packaged and sold separately, but are referred to collectively, in all associated product labeling, as the INNOFLUOR® Gentamicin Assay System. The INNOFLUOR® Gentamicin Assay System is an in vitro diagnostic device intended for the quantitative determination of total Gentamicin in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer. The INNOFLUOR® Gentamicin Reagent Set is intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Gentamicin Assay System. The INNOFLUOR® Gentamicin Calibrator Set is intended for use in the calibration of the INNOFLUOR® Gentamicin Assay System. The INNOFLUOR® Gentamicin Reagent Set and Calibrator Set are used together to generate the calibration curve on the TDx®/TDxFLx® analyzer. 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® Gentamicin Reagent Set.

Source page: https://510kreport.com/device/K972331
Methodology: https://510kreport.com/methodology