(39 days)
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No
The description focuses on a fluorescence polarization immunoassay and standard statistical analysis (linear regression, correlation coefficient) for performance evaluation. There is no mention of AI or ML terms, image processing, or training/test sets in the context of model development.
No
Explanation: The device is an in vitro diagnostic device used for quantitative determination of gentamicin in serum, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device."
No
The device description explicitly states it is an "in vitro diagnostic device" and an "assay system" consisting of a "Reagent Set" and a "Calibrator Set," which are physical components used with an analyzer. This indicates it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement clearly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INNOFLUOR® Gentamicin Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
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.
Product codes
LGQ
Device Description
The INNOFLUOR® Gentamicin Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. 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
serum
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
69 patient samples from patients receiving gentamicin 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 equations: (INNOFLUOR®, Modified) = 0.985 x (Abbott) - 0.107, with a correlation coefficient of 0.9928 and (INNOFLUOR®, Modified) = 1.037 x (INNOFLUOR®, Existing) - 0.045, with a correlation coefficient of 0.9947, demonstrating equivalency of results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K 972331
AUG - 1 - 1997
510(k) SUMMARY INNOFLUOR® GENTAMICIN REAGENT SET
Trade Name: INNOFLUOR® Gentamicin Assay System, which consists of two products that are packaged and sold separately: the INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set.
Gentamicin Fluorescence Polarization Immunoassay Common or Usual Name:
Classification Name: Fluorescence Polarization Immunoassay, Gentamicin
The INNOFLUOR® Gentamicin Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
Substantial equivalence has been demonstrated between the INNOFLUOR® Gentamicin Assay System, Modified, the INNOFLUOR® Gentamicin Assay System, Existing and the Abbott Gentamicin Assay.
The technological characteristics, performance and intended use of the INNOFLUOR® Gentamicin Assay System, Modified are substantially equivalent to the INNOFLUOR® Gentamicin Assay System, Existing and the Abbott Gentamicin Assay.
Gentamicin concentrations measured by the INNOFLUOR® Gentamicin Assay System. Modified, (INNOFLUOR®, Modified), and the INNOFLUOR® Gentamicin Assay System, Existing, (INNOFLUOR®, Existing), were compared with those measured by the Abbott Gentamicin Assay (Abbott), using the Abbott TDx® analyzer, on 69 patient samples from patients receiving gentamicin therapy. Comparison of the patient sample results by linear regression analysis resulted in the regression equations: (INNOFLUOR®, Modified) = 0.985 x (Abbott) - 0.107, with a correlation coefficient of 0.9928 and (INNOFLUOR®, Modified) = 1.037 x (INNOFLUOR®, Existing) - 0.045, with a correlation coefficient of 0.9947, demonstrating equivalency of results.
Contact Person: Lvnda M. Tavlor Vice President, Technical Operations and Requlatory Affairs
Date Prepared: April 22, 1997
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 1 1997 .
Lynda M. Taylor Vice President, Technical Operations OXIS International, Inc. 6040 N. Cutter Circle, Suite 317 Portland, Oregon 97217-3935
Re : K972331 INNOFLUOR™ Gentamicin Reagent Set Regulatory Class: II Product Code: LGQ Dated: June 20, 1997 Received: June 23, 1997
Dear Ms. Taylor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC). at (770) 488-7655.
This letter will allow you to begin marketing your device as ------described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Numbe
TDx® and TDxFLx® are registered trademarks of Abbott Laboratories, Inc., Abbott Park, IL 60064