(23 days)
Not Found
MicroScan® WalkAway, autoSCAN-4
No
The summary describes a traditional antimicrobial susceptibility testing panel and associated instrumentation, with no mention of AI or ML in the intended use, device description, or other sections. The software mentioned is a standard laboratory information system platform.
No.
The device is used to determine antimicrobial agent susceptibility, which aids in diagnosis and treatment selection, but it does not directly treat or prevent a disease or condition.
Yes
The device "determines quantitative and/or qualitative antimicrobial agent susceptibility" of bacterial colonies, which is a form of in vitro diagnostic testing to guide treatment.
No
The summary describes a physical panel (MicroScan® Dried Gram-Positive MIC/Combo Panel) used for susceptibility testing, which is a hardware component. While software is mentioned for reading the panels, the core device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device 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-positive cocci." This is a classic example of an in vitro test performed on biological samples (bacterial colonies) to provide information about a patient's condition (susceptibility to antibiotics).
- Sample Type: The device uses "colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci," which are biological samples derived from a patient.
- Purpose: The purpose is to determine antimicrobial susceptibility, which is crucial for guiding treatment decisions for bacterial infections. This information is used in vitro to diagnose or monitor a patient's health status.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This submission is to evaluate the performance of the antimicrobial agent Erythromycin on the MicroScan® Dried Gram-Positive MIC/Combo Panels read on MicroScan® WalkAway and autoSCAN-4 Instruments utilizing the current DMS or LabPro version
§ 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2006
Ms. Shannon Popson Regulatory Affairs Manager Dade Behring 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
Re: K062179
Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (0.25 - 16 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: II Product Code: LRG Dated: July 24, 2006 Received: July 31, 2006
Dear Ms. Popson:
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. Iisting 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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Sally, artom
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-Positive MIC/Combo Panels with Erythromycin Device Name: (0.25 - 16 µg/ml)
Indications For Use:
The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This submission is to evaluate the performance of the antimicrobial agent Erythromycin on the MicroScan® Dried Gram-Positive MIC/Combo Panels read on MicroScan® WalkAway and autoSCAN-4 Instruments utilizing the current DMS or LabPro version (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)
gnostic Devices (OIVD)
Division Sign Off
ivision Sign-Off
Office of In Vito Diagnostic Device Evaluation and Satery
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