(11 days)
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. Panels are incubated for 16 - 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms.
The Gram-Negative organisms which may be used for Amoxicillin/K. Clavulanate susceptibility testing in this panel are:
Enterobacter species
Escherichia coli
Klebsiella species
Proteus mirabilis
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a change to a currently marketed device, specifically the performance evaluation for a reformulated antimicrobial agent (Amoxicillin/K. Clavulanate) on MicroScan® Dried Gram-Negative MIC/Combo Panels.
It describes the FDA's decision to clear the device, but it does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in the manufacturer's submission or a separate study report.
Therefore, I cannot provide the requested information from the text you provided. The document focuses on the regulatory outcome rather than the specifics of the underlying performance study.
To answer your request, I would need access to the actual 510(k) submission document (e.g., the "traditional 510(k)" or "special 510(k)" submission) prepared by Dade MicroScan Inc. This submission would contain the detailed study protocols, results, and analysis.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure embracing a three-tiered symbol, which is meant to represent life and well-being.
MAR 1 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert Eusebio Regulatory Affairs Manager Dade MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K050585 Re:
K050585
Trade/Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels MicroScan - Dried Grain ate (0.25/0.12 - 128/64 ug/ml) Regulation Number: 21 CFR 866.1645, 866.1640
Regulation Number: 21 CFK 800.1643, 800.1045.
Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system.
Regulatory Class: Class II Product Code: LRG Dated: February 28, 2005 Received: March 7, 2005
Dear Mr. Eusebio:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(k) prematic is substantially equivalent (for the indications
referenced above and have determined the device is subsets marketed in intersta referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced provice Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the chacmient with the provisions of the Federal Food, Drug, devices that have been recults in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of Y ou may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements michreading and general controls provisions of the frectments required in the summer misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into e. Existing major regulations affecting your device in addition. In it may be subject to such additional controllar Britishig kirk can be found in Title 21, Code of Pederal regarated in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualitat equires with other requirements of the Act
that FDA has made a determination that your device complises - You must that FDA has made a decemmanon that your as roos by other Federal agencies. You must be and ligit or any Federal statutes and regulations administered of registration and listing (21 comply with an the Act 3 requirements, me and 809); and good manufacturing practice CFR Part 807), labeling (21 CFR Parts (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of allers of a location to the spiralement of your de This letter will allow you to begin makemily of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of you premarket notification. The PDA Inding of Justical one of the super 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, a If you desire specific information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please note t or questions on the promotion and ad rertising or years . Also, please note the Vitro Diagnosic Device Lyadianon and Bareer at (21). " (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification Ast from the regulation entitled, "Misolanding by reicher to presponsibilities under the Act from the You may obtain other general information on your respectives 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,
Sally, a Hoy
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 STATEMENT
Page _ 1_of_1.
510(k) Number (if known):
MicroScan® Dried Gram-Negative MIC/Combo Panels with Amoxicillin/K. Device Name: Clavulanate (0.25/0.12 - 128/64 ug/ml)
Indications For Use:
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine The Microbiative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative on solly modia or rapiers grows are incubated for 16 - 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms.
The Gram-Negative organisms which may be used for Amoxicillin/K. Clavulanate susceptibility testing in this panel are:
Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis
Prescription Use র্স (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Augmentin AS4.DOC
Office of In 'i "Inclie Device Evaluation and
510(k) K050585
Division Sign-Off
§ 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).