(60 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram neqative orqanisms. This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.002 - 16 ug/ml for testing gram positive and 0.002 - 4 ug/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Gemifloxacin is for: Klebsiella pneumonia. Gemifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of (0.25ug/mL) or less against most (≥90%) of the following microorganisms: however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and wellcontrolled clinical trials. Staphylococcus aureus (Methicillin-susceptible strains only) Streptococcus pyogenes Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris.
Susceptibility Test Panel for Gemifloxacin 0.002-4μg/ml Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml Gram Positive
This document is a 510(k) clearance letter for an antimicrobial susceptibility test panel. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a legally marketed predicate device.
However, the provided text DOES NOT contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the comprehensive study details you've requested.
The document states that the FDA has "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent...". This implies that the applicant (TREK Diagnostic Systems, Inc.) submitted data and information to support their claims. However, this specific letter does not present that data, nor does it lay out the acceptance criteria used by the FDA for making its determination.
Therefore, I cannot provide the information you requested based on the given text.
To answer your questions, one would need access to the full 510(k) submission (K053243) from TREK Diagnostic Systems, Inc., which would contain the study protocols, raw data, analysis, and stated acceptance criteria.
Based on the provided text, the following aspects are completely unknown:
- Acceptance Criteria Table: Not present.
- Reported Device Performance: Only the claimed MIC ranges are mentioned for Gemifloxacin, but no performance metrics (e.g., accuracy, sensitivity, specificity, or categorical agreement) are given.
- Sample Size (Test Set): Not mentioned.
- Data Provenance (Test Set): Not mentioned.
- Number of Experts (Ground Truth): Not mentioned.
- Qualifications of Experts (Ground Truth): Not mentioned.
- Adjudication method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned as being performed for this particular 510(k). This type of study is more common for imaging AI devices rather than AST panels.
- Effect size of human reader improvement: Not applicable given the type of device and lack of MRMC study description.
- Standalone (algorithm only) performance: This device is a manual or semi-automated system for reading MICs, so the concept of an "algorithm only" performance as typically applied to image-based AI would not directly apply without further context on how "standalone" would be interpreted for an AST panel. However, the study would have involved comparing the device's readings to a reference method (the "ground truth").
- Type of Ground Truth: While it can be inferred that the ground truth for an AST panel would be a reference AST method (e.g., broth microdilution or agar dilution as established by CLSI), the specific method used is not detailed in this document.
- Sample Size (Training Set): Not mentioned.
- Ground Truth for Training Set: Not mentioned.
In summary, this document is a regulatory approval letter, not a scientific study report or a detailed summary of the performance data submitted for approval.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 2006
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Brooklyn Heights, OH 44145
K053243 Re:
Trade/Device Name: Susceptibility Test Panel for Gemifloxacin 0.002-4μg/ml Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml Gram Positive Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LRG, JWY Dated: November 18, 2005 Received: December 5, 2005
Dear Ms. Knapp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sale, a For
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053243
Device Name: Susceptibility Test Panel for Gemifloxacin 0.002-4ug/ml for Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml for Gram Positive
Indications For Use:
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product
for clinical susceptibility testing of gram positive and gram neqative orqanisms.
This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.002 - 16 ug/ml for testing gram positive and 0.002 - 4 ug/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Gemifloxacin is for:
Klebsiella pneumonia.
Gemifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of (0.25ug/mL) or less against most (≥90%) of the following microorganisms: however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and wellcontrolled clinical trials.
Staphylococcus aureus (Methicillin-susceptible strains only) Streptococcus pyogenes Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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510(k) Number 053243
§ 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).