SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID by AB BIODISK

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/Amoxicillin/clavulanic acid susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4/2 µg/ml and Resistant ≥ 8/4 µg/ml for use with Staphylococcus, and Susceptible ≤ 8/4 µg/ml, Intermediate 16/8 µg/ml and Resistant ≥ 32/16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

Device Description

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria. 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.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called "System U3™ for Amoxicillin/clavulanic acid," which is used for antimicrobial susceptibility testing. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include details about specific acceptance criteria or the study used to prove the device meets those criteria. This type of information is typically found within the full 510(k) submission, not in the clearance letter itself.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.

Based on the nature of the document, the following points can be inferred:

Device Type: In vitro diagnostic device for antimicrobial susceptibility testing.
Regulatory Classification: Class II.
Purpose: To determine the susceptibility categories (Susceptible, Intermediate, Resistant) of microorganisms to Amoxicillin/clavulanic acid.
Ground Truth (implied for test set): Likely based on established antimicrobial susceptibility testing methods and MIC breakpoints, which are specified in the "Indications for Use" (e.g., Susceptible ≤ 4/2 µg/ml for Staphylococcus).
Study Type (implied): For devices like this, the FDA typically requires studies demonstrating agreement with a predicate device or established reference method across a range of bacterial isolates with known susceptibility profiles. However, the specifics of such a study (sample size, expert involvement, adjudication, etc.) are not in this document.

To answer your questions, I would need access to the full 510(k) submission or a summary of its data.

Summary

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FEB - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K984144

Trade Name: System U3TM for Amoxicillin/clavulanic acid Regulatory Class: II Product Code: JWY Dated: November 13, 1998 Received: November 18, 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 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 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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510(k) Number (if known):

Device Name: System U3™ for Amoxicillin/clavulanic acid

Indications For Use:

For in vitro diagnostic use:

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

Concurrence of CDRH, Office of.Device Evaluation (ODE)

	Woody Dubes
	(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number	K984144
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Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The Counter Use
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(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).