(21 days)
Not Found
LGQ
No
The description focuses on a fluorescence polarization immunoassay for therapeutic drug monitoring, a standard in vitro diagnostic technique. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic device used to measure the concentration of phenobarbital in serum for therapeutic drug monitoring, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device..."
No
The device is an in vitro diagnostic assay system consisting of reagent sets and calibrator sets, which are physical components used with a specific analyzer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "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..." This directly identifies it as an IVD.
- Device Description: The description further reinforces this by stating "The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device used to monitor serum levels of the therapeutic, anticonvulsant drug, phenobarbital."
- Nature of the Test: The assay is performed on serum samples (biological material) to measure a substance (phenobarbital) for medical purposes (therapeutic drug monitoring). This is a hallmark of an in vitro diagnostic test.
- Components: The system includes reagents and calibrators, which are typical components of IVD kits used for laboratory testing.
The information provided clearly indicates that this device is designed to be used outside of the body (in vitro) to examine specimens (serum) for diagnostic or therapeutic purposes (monitoring drug levels).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LGQ
Device Description
The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device used to monitor serum levels of the therapeutic, anticonvulsant drug, phenobarbital.
The INNOFLUOR® Phenobarbital Assay System consists of the following two products which are packaged and sold separately, but are referred to collectively, in associated product labeling and in this 510(k) Notification as the INNOFLUOR® Phenobarbital Assay System. Neither the reagent set nor the calibrator set are intended to be used separately nor in combination with any other manufacturer's reagent or calibrator sets.
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INNOFLUOR® Phenobarbital Reagent Set, Catalog No. 11013, sufficient for 100 tests, consists of the following reagents:
§ 862.3660 Phenobarbital test system.
(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.
0
972330
DEVICE NARRATIVE
JUL 1 4 1997
IDENTIFICATION OF SUBMITTER
Submitter: OXIS International, Inc. 6040 N Cutter Circle, Suite 317 Portland, OR 97217-3935
Contact Person: Lynda M. Taylor Vice President, Technical Operations and Regulatory Affairs
Date Prepared: April 25, 1997
IDENTIFICATION OF DEVICE
Trade Name: INNOFLUOR® Phenobarbital Assay System, which consists of two products that are packaged and sold separately: the INNOFLUOR® Phenobarbital Reagent Set and the INNOFLUOR® Phenobarbital Calibrator Set.
Common or Usual Name: Phenobarbital Fluorescence Polarization Immunoassay
Classification Name: Fluorescence Polarization Immunoassay, Phenobarbital
IDENTIFICATION OF EQUIVALENT DEVICE
Substantial equivalence has been demonstrated between the INNOFLUOR® Phenobarbital Assay System. Modified, the INNOFLUOR® Phenobarbital Assay System, Existing and the Abbott Phenobarbital Assay.
DEVICE DESCRIPTION
THE INNOFLUOR PHENOBARBITAL ASSAY SYSTEM:
The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device used to monitor serum levels of the therapeutic, anticonvulsant drug, phenobarbital.
Phenobarbital is a barbiturate that has been used extensively as an anticonvulsant since 1912 (1.2). It is generally administered to epileptic patients in oral doses, often in conjunction with other anticonvulsant drugs. Oral absorption of phenobarbital is complete but slow, with peak plasma concentration reached several hours after intake.(1) Approximately 50% of the drug is bound to plasma proteins, with binding to a similar extent in tissue.(1) After dosing, 25-50% is excreted unchanged in the urine.(3) The remainder is metabolized almost exclusively in the liver to inactive metabolites, mainly the parahydroxyphenyl and N-glucoside derivatives.(1,4,5)
Monitoring serum concentrations of phenobarbital has been recommended for effective patient therapy because of the narrow therapeutic index and wide interindividual variability in the rate of metabolism and clearance of phenobarbital.(6.7) Immunoassays using a fluorescence polarization technique for phenobarbital have been published.(8,9) (See Attachment C, the INNOFLUOR® Phenobarbital Assay System package insert, Bibliography, for references.)
1
The INNOFLUOR® Phenobarbital Assay System consists of the following two products which are packaged and sold separately, but are referred to collectively, in associated product labeling and in this 510(k) Notification as the INNOFLUOR® Phenobarbital Assay System. Neither the reagent set nor the calibrator set are intended to be used separately nor in combination with any other manufacturer's reagent or calibrator sets.
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INNOFLUOR® Phenobarbital Reagent Set, Catalog No. 11013, sufficient for 100 tests, 1. consists of the following reagents: