# K972330: Innofluor Phenobarbital Assay System

- Pathway: 510(k) (Traditional)
- Applicant: Oxis Intl., Inc.
- Decided: Jul 14, 1997 after 21 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® Phenobarbital Assay System, Existing: named in the summary without a submission number
- (no number) Abbott Phenobarbital Assay: named in the summary without a submission number

## Indications for use
The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device intended for the quantitative determination of total Phenobarbital 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® Phenobarbital Reagent Set is intended for the quantitative determination of total phenobarbital in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Phenobarbital Assay System. The INNOFLUOR® Phenobarbital Calibrator Set is intended for use in the calibration of the INNOFLUOR® Phenobarbital Assay System. The INNOFLUOR® Phenobarbital 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® Phenobarbital Reagent Set.

Source page: https://510kreport.com/device/K972330
Methodology: https://510kreport.com/methodology