(90 days)
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No
The document describes a standard fluorescence polarization immunoassay system and does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is described as an "in vitro diagnostic device" used for quantitative determination of topiramate in serum or plasma. It aids in achieving appropriate therapy by measuring drug concentrations but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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." This clearly identifies it as a diagnostic device.
No
The device is described as an in vitro diagnostic assay system that includes reagent sets and calibrator sets for use on specific hardware analyzers (Abbott TDx® or TDxFLx®). This indicates it is a system with both chemical reagents and intended use with hardware, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device.
- Nature of the Test: The device performs a quantitative determination of total topiramate in serum or heparinized plasma. This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic.
- Purpose: The purpose of the test is to measure topiramate concentrations to aid in achieving appropriate therapy. This is a diagnostic purpose, providing information to guide clinical decisions.
- Components: The description mentions a "Reagent Set" and "Calibrator Set," which are typical components of IVD assay systems.
The information provided clearly indicates that this device is designed and intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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 or TDxFLx®) analyzer.
The INNOFLUOR™ Topiramate Reagent Set is intended for the quantitative determination of total topiramate in serum or heparinized plasma. The reagent set in 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 on the TDx or 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™ Topiramate Reagent Set. The INNOFLUOR™ Topiramate Control Set is intended for use in the quality control of the INNOFLUOR™ Topiramate Assay System. 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.
Product codes (comma separated list FDA assigned to the subject device)
MSL, DIP
Device Description
The INNOFLUOR™ Topiramate Assay System is a 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® analyzer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Topiramate concentrations measured by the INNOFLUOR™ Topiramate Assay System (INNOFLUOR™), on the Abbott TDx® analyzer, were compared with those measured by Topiramate Gas Chromatography (GC) on 117 patient samples from patients receiving Topiramate therapy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/3 description: The image shows the logo for OXIS International, Inc. The logo features a stylized square with a partial circle and a line extending from it on the left side. To the right of the square is the word "OXIS" in large, bold, sans-serif font. Below "OXIS" is the text "International, Inc." in a smaller, serif font.
MAY 1 2 1997
690(k) SUMMARY INNOFLUOR™ TOPIRAMATE REAGENT SET
Trade Name: INNOFLUOR™ Topiramate Assay System, which consists of three products that are packaged and sold separately: the INNOFLUOR™ Topiramate proodse that are personalism and believe or set and the INNOFILUOR™ Topiramate Control Set.
Topiramate Fluorescence Polarization Immunoassay Common or Usual Name:
Clessification Name: Fluorescence Polarization Immunoassay, Topiramate
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization The INNOF LOON heparinized plasma. Topiramate serum or heparinized plasma concentrations are measured to ald in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
Substantial equivalence has been demonstrated between the INNOFLUOR™ Topiramate Assay System, the INNOFLUOR™ Phonoberbital Assay System INNOFLUOR™ Phenobarbital Reagent Set and INNOFLUOR™ Phonobarbitel Callbrator Set), the Abbott Phenobarbilal II Assay and Topiramate Gas Chromatography.
The technological characteristics, performance and intended use of the INNOFLUOR™ Topiramate Assay System are substantially equivalent to the INNOFLUOR™ Phenobarbital Assay System and the Abbott Phenobarbital II Assay with the exception of the specific anticonvulsant tested for by each method.
Topiramate concentrations measured by the INNOFLUOR™ Topiramate Assay System (INNOFLUOR™), on the Abbott TDx® analyzer, were compared with those measured by Toplramate Gas Chromatography (GC) on 117 patient samples from patients receiving Topiramate therapy. Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results.
Contact Person:
Lynda M. Taylor Vice President Quality Assurance and Regulatory Affairs
05/09/97 Date Propared:
A3
Corporate Headquarters 6040 N. Curser Crose, Suite 317, Pordand, OR 97217-3935 Voice: 503-283-3911 · 800 547-3686 · Facsimile: 503-203-4058
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Letter date: November 2, 2012
OXIS International c/o Lynda M. Taylor 6040 N. Cutter Circle, Suite 317 Portland, OR 97217-3935
Re: K970510
Trade/Device Name: INNOFLUOR™ Topiramate Reagent Set Regulation Number: 21 CFR8862.3350 Regulation Name: Diphenylhydantoin Test System Regulatory Class: II Product Code: MSL, DIP Dated: February 7, 1997 Received: February 11, 1997
Dear Ms. Taylor:
This letter corrects our substantially equivalent letter of May 12, 1997.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDevices/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson on Soleson Covennent ou=HB,
Digitally signed by Carol C. Benson DN: c=US, o=U.S. Government, ou=HHS, 0.9.2342.19200300.100.1.1=1300086490 Date: 2012.11.02 15:28:26 -04'00,
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (lf known); K970510
Device Name:INNOFLUOR Topiramate Reagent Set
Indications For Use:
The INNOFLUOR™ Topinamate Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR ™ Topiramata Control Set are packaged and sold separately, but are referred to collectively, in all associated product labeling, as the INNOFLUOR™ Topitamare Assay System.
ﮯ - ﺍﻧﮯ ۔
The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quartitative detentification of total topinames in serum or heparinized plaema by fiuorescence polarization immunesses. Topiramate serum or heparinized plaams concentrations are measured to ald in achieving appropriate therepy. The assey system is for use on the Abbott TDx® or the TDxFLx® (TDxDrTDxFLx®) analyzer.
The INNOFLUOR™ Topiramate Reager: Set is intensed for the quentitutive determination of total topiramate in serum or heparinized plasma. The reagent set in intended for use in the INNOFLUOR ™ Topiramate Assay System. The INNOFLUOR™ Topinamale Callunator Set Is intended for use in the callbration of the INNOFLUOR™ Topinamate Assoy Dystem. The INNOFLUOR ™ Tephamate Reagent Set and Callerator Set are used together to generate the callbration curve on the TDxfFLxFLyde analyzer. The calleration curve must be established prior to asseying unitscoun samples. Prior to performing the calleration processure, the correct analyzer operating peramators must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR™ Topiramate Reagent Set. The INNOFLUQR™ Teplanale Control Sol la Linded or use the quality control of the United Of Drivel Of Deless of the United Of the Controls
INNOFLUOR™ Technolo Ausey Dystem The C have been selected to best monitor the quality and stability of the callbration curve. The control results must be within established acceptable ranges before patient carryles are asseyed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NE = 9 : 30 )
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K976510 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-98)