SYSTEM U3 FOR GENTAMICIN by AB BIODISK NORTH AMERICA, INC.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Gentamicin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 g/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "System U3™ for Gentamicin." It doesn't contain information about acceptance criteria or a dedicated study proving the device meets said criteria in the way a clinical trial report would.

However, based on the provided text, we can infer some aspects relevant to its regulatory acceptance and what would be expected for such a device. Since this is a 510(k) submission, the primary criterion for acceptance is substantial equivalence to a legally marketed predicate device.

Here's an analysis of what can be gleaned, and where information is missing for a complete answer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (Inferred/Expected)
Substantial Equivalence: Device performs as safely and effectively as a predicate device for its intended use.	"Determined the device is substantially equivalent" to legally marketed predicate devices. (Stated in the letter)
Accuracy of Susceptibility Categorization: Correctly determine susceptibility categories (Susceptible, Intermediate, Resistant) based on MIC breakpoints.	The System U3™ for Gentamicin is for susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml, and Resistant ≥ 16 µg/ml. (Implied that the device achieves this in comparison to a predicate, as per substantial equivalence). The specific accuracy percentages are not provided here.
Reproducibility/Reliability: Consistent results when tested under similar conditions.	Not explicitly stated in this letter, but would be a standard part of any validation study for such a device.
Intended Use: For in vitro diagnostic use, for antimicrobial susceptibility testing of non-fastidious Gram negative and Gram positive aerobic bacteria (e.g., Enterobacteriaceae, Pseudomonas, Staphylococcus, Enterococcus species).	The device's indications for use are exactly as described in the acceptance criteria.
Compliance with MIC Breakpoints: Adherence to established MIC breakpoints for Gentamicin.	"based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml". (Stated in the indications for use).

Note: The FDA 510(k) clearance letter confirms that the device has met the criteria for substantial equivalence, allowing it to be marketed. However, it does not detail the specific study results that led to this conclusion. Those details would be in the original 510(k) submission file, which is not provided here.

Based on the provided text, the following information is either not present or cannot be definitively extracted:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/mentioned for this type of in vitro diagnostic device (antibiotic susceptibility testing). MRMC studies are usually for imaging diagnostics where human interpretation is a significant factor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "System U3" is a qualitative technique, not an "algorithm" in the modern AI sense. It determines susceptibility categories, likely through a standardized method that is inherently standalone in its result generation, even if a human reads the final result. However, the exact performance metrics of such a standalone component are not detailed here.
7. The type of ground truth used: Not explicitly stated, but for antimicrobial susceptibility testing devices, the "ground truth" is typically established by reference methods (e.g., broth microdilution or agar dilution as described by CLSI guidelines), which are considered the gold standard for determining MIC values.
8. The sample size for the training set: Not applicable and not mentioned. This device is not described as an AI/ML algorithm that requires a training set in the contemporary sense. It's an established qualitative technique.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided document is a regulatory clearance letter, not a detailed study report. It confirms the device's market approval based on the FDA's assessment of the 510(k) submission, which would have contained the underlying performance data and justification for substantial equivalence.

Summary

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NOV 20 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Anne Bolmström President AB BIODISK Dalvägen 10 S-169 56 Solna Sweden

Re: K983252

Trade Name: System U3™ for Gentamicin Regulatory Class: II Product Code: JWY Dated: September 14, 1998 Received: September 16, 1998

Dear Ms. Bolmström:

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 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). 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 regulatory 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 vour 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 premarket notification" (21 CFR 807.97). 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Butman

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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Page 1 of 1

510(k) Number (if known):

Device Name: System U3™ for Gentamicin

Indications For Use:

For in vitro diagnostic use:

System U374 is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)




(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number	K983252
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Prescription Use		OR	Over-The Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).