← Product Code [LRG](/productcode/LRG) · K062179 # MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) (K062179) _Dade Behring, Inc. · LRG · Aug 23, 2006 · Microbiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K062179 ## Device Facts - **Applicant:** Dade Behring, Inc. - **Product Code:** [LRG](/productcode/LRG.md) - **Decision Date:** Aug 23, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.1640 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## 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 <2.0 Software platforms. The Gram-Positive organisms which may be used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus ## Device Story MicroScan® Dried Gram-Positive MIC/Combo Panels facilitate antimicrobial susceptibility testing (AST) for gram-positive cocci. Device utilizes dried antimicrobial agents (Erythromycin 0.25-16 µg/ml) within panel wells. Clinical laboratory personnel inoculate panels with bacterial colonies grown on solid media; panels are incubated for 16-20 hours at 35°C in non-CO2 environments. Results are determined via visual inspection or automated reading using MicroScan® WalkAway or autoSCAN-4 instruments. Automated systems process optical data to provide quantitative or qualitative susceptibility results. Healthcare providers use these results to guide antibiotic therapy decisions for patients with bacterial infections. ## Clinical Evidence Bench testing only. Performance of Erythromycin on MicroScan® Dried Gram-Positive MIC/Combo Panels was evaluated by comparing results to a reference method. Testing confirmed the device's ability to provide accurate antimicrobial susceptibility results for Staphylococcus aureus. ## Technological Characteristics Dried antimicrobial susceptibility panel; 96-well format; contains dehydrated Erythromycin (0.25-16 µg/ml). Compatible with MicroScan® WalkAway and autoSCAN-4 instrumentation. Operates via optical detection of bacterial growth inhibition. Software-controlled analysis via DMS or LabPro platforms. ## Regulatory 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. ## Predicate Devices - MicroScan® Dried Gram-Positive MIC/Combo Panels ([K062179](/device/K062179.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ #### 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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 <2.0 Software platforms. The Gram-Positive organisms which may be used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus Prescription Use _____________________________________________________________________________________________________________________________________________________________ > (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 Unb 2179 - 1 5 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 --- **Source:** [https://fda-staging.innolitics.com/device/K062179](https://fda-staging.innolitics.com/device/K062179) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com