(65 days)
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.
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I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, and ground truth establishment for a medical device.
The document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin." This letter indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. While it mentions the "indications for use" and the product code, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the type of study conducted to demonstrate performance (e.g., test set, training set, retrospective/prospective).
- Information about experts used for ground truth, adjudication methods, or the type of ground truth.
- Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
The letter is a regulatory document confirming clearance, not a scientific study report with performance metrics.
To answer your questions, I would need access to the actual 510(k) submission document or a scientific paper detailing the validation study for this device.
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NOV 2 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cynthia C. Knapp Director Lab Services AccuMed International, Inc. 29299 Clemens Road. Suite 1-K Westlake, OH 44145
Re: K983301 Trade Name: Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin Regulatory Class: II Product Code: JWY Dated: September 3, 1998 Received: September 21, 1998
Dear Ms. Knapp:
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):
Jevice Name: Susceptibility Test Panel
Indications For Use:
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
Division Sign-Off) Division of Clinical Laboratory Devices K983301 510(k) Number _
Prescription Use
X
(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).