INNOFLUOR GENTAMICIN ASSAY SYSTEM by OXIS INTL., INC.

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.

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. The system consists of the INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set, which are packaged and sold separately.

AI/ML Overview

This 510(k) summary describes a new version of an existing device, the INNOFLUOR® Gentamicin Assay System, referred to as "INNOFLUOR®, Modified." The submission aims to demonstrate substantial equivalence to the previously existing INNOFLUOR® Gentamicin Assay System ("INNOFLUOR®, Existing") and the Abbott Gentamicin Assay. The study described is a comparison study, not a standalone performance study in the traditional sense, as it relies on comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of specific thresholds for the regression analysis (e.g., a minimum correlation coefficient or acceptable slope/intercept range). Instead, the submission implies that showing strong correlation and close agreement to the predicate devices constitutes meeting the acceptance criteria for substantial equivalence.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (INNOFLUOR®, Modified)
Comparison to Abbott Gentamicin Assay	Strong linear correlation and close agreement	Regression Equation: (INNOFLUOR®, Modified) = 0.985 x (Abbott) - 0.107Correlation Coefficient (r): 0.9928
Comparison to INNOFLUOR®, Existing	Strong linear correlation and close agreement	Regression Equation: (INNOFLUOR®, Modified) = 1.037 x (INNOFLUOR®, Existing) - 0.045Correlation Coefficient (r): 0.9947

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 69 patient samples
Data Provenance: The samples were from "patients receiving gentamicin therapy," implying retrospective samples collected from a clinical setting. The country of origin is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This study does not involve expert-established ground truth in the typical sense of diagnostic imaging or clinical interpretation. The "ground truth" for this study is effectively the results obtained from the predicate devices (Abbott Gentamicin Assay and INNOFLUOR®, Existing).

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison study, not one requiring adjudication of diagnostic outcomes. The comparison is based on the numerical results of each assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a laboratory assay for therapeutic drug monitoring, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The INNOFLUOR® Gentamicin Assay System, Modified, is the "algorithm" (the assay system) being tested in a standalone manner against two predicate devices. The study compares the quantitative output of the device itself to the quantitative output of other devices. There is no human intervention in the performance of the assay or the generation of its initial result, beyond sample preparation and loading onto the analyzer.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate devices: the Abbott Gentamicin Assay and the INNOFLUOR®, Existing Gentamicin Assay. The study aims to show that the new device's results are equivalent to these established methods.

8. The Sample Size for the Training Set

Not applicable. This device is a biochemical assay and does not appear to involve machine learning models that require a "training set" in the computational sense. The "training" for such assays typically involves method development, optimization, and validation experiments by the manufacturer, rather than a distinct "training set" of patient data for an AI model.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/ML device, the concept of a "training set" and its ground truth in that context does not apply. The development of such an assay would involve extensive analytical validation, including studies of accuracy, precision, linearity, and interference, using reference materials and spiked samples with known gentamicin concentrations. These are internal validation processes by the manufacturer, not typically described as establishing "ground truth for a training set" in a regulatory submission like this.

Summary

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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

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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Paqe 2

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 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

Regulation Number and Section

§ 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.