(84 days)
For in vitro diagnostic use: 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/Nitrofurantoin susceptibility testing based on the MIC breakpoints of Susceptible 5 32 yylml, Intermediate 64 ug/ml and Resistant ≥ 120 ug/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria from urines only.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "System U3TM for Nitrofurantoin." It describes its intended use for antimicrobial susceptibility testing. The provided text does not contain the detailed information needed to answer the specific questions about acceptance criteria and study design elements you've requested.
The letter explicitly states: "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... to legally marketed predicate devices." This means the FDA found the device to be similar enough to an existing approved device that it doesn't need to undergo the more rigorous premarket approval process.
To gain insights into the acceptance criteria and the study that proves the device meets them, you would typically need to refer to the original 510(k) submission itself (K983562), which would contain a comprehensive description of the device, its performance data, and the comparison to the predicate device.
Therefore,Based on the provided text, I cannot extract the information required to populate the fields you requested. The document is a 510(k) marketing clearance letter, not a performance study report.
Here's why and what's missing:
- Acceptance Criteria and Reported Device Performance: This letter only states "substantially equivalent" to predicate devices. It doesn't detail performance metrics or specific acceptance criteria met by the System U3.
- Sample Size, Data Provenance, Expert Information, Adjudication: These are all details of the study that would have been submitted in the 510(k) to demonstrate substantial equivalence, but are not present in this clearance letter.
- MRMC study, Standalone performance: These types of studies would be described in the 510(k) submission, not summarized in the clearance letter.
- Ground Truth Type, Training Set Size, Training Set Ground Truth: Similar to above, these are elements of a detailed study report that are not included in this document.
To get answers to your questions, you would need to access the full 510(k) submission for K983562, which would contain the performance data and study details that the FDA reviewed to make its substantial equivalence determination.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three stylized human figures or profiles facing to the right, resembling a bird in flight.
JAN - 5 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Anne Bolmström President AB BIODISK Dalvägen 10 S-169 56 Solna Sweden
K983562 Re: Trade Name: System U3TM for Nitrofurantoin Regulatory Class: II Product Code: JWY, JTT Dated: October 8, 1998 Received: October 13, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Sutman
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 U3Td for Nitrofurantoin
Indications for Use:
For in vitro diagnostic use:
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/Nitrofurantoin susceptibility testing based on the MIC breakpoints of Susceptible 5 32 yylml, Intermediate 64 ug/ml and Resistant ≥ 120 ug/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria from urines only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Woody Dubac | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983565 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 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).