← Product Code [LRG](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG) · K063102 # MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (K063102) _Dade Behring, Inc. · LRG · Nov 9, 2006 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG/K063102 ## Device Facts - **Applicant:** Dade Behring, Inc. - **Product Code:** [LRG](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG.md) - **Decision Date:** Nov 9, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1640 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Intended Use To determine bacterial antimicrobial agent susceptibility ## Device Story MicroScan® MICroSTREP plus® Panel is a 96-well plastic dish containing dehydrated antimicrobial agents; rehydrated with Mueller-Hinton broth and lysed horse blood (2–5%) after inoculation with standardized organism suspension (approx. 5 x 10⁵ CFU/mL). Panels incubated 20-24 hours at 35°C. Device uses optics light detection to measure growth in wells; determines Minimum Inhibitory Concentration (MIC) based on inhibition of growth. Used in clinical microbiology laboratories; operated by technicians. Automated reading via MicroScan® WalkAway System provides quantitative/qualitative susceptibility results. Output assists clinicians in selecting appropriate antibiotic therapy for Streptococcus pneumoniae infections. ## Clinical Evidence Performance evaluated using stock and CDC Challenge strains. Comparison of instrument-read results against expected results (CLSI frozen reference panels). Overall Essential Agreement for Cefaclor was 92.5%. Reproducibility, precision, and quality control testing demonstrated acceptable performance. ## Technological Characteristics Miniaturized broth dilution panel; rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES. Incubation at 35°C +/- 1°C. Manual or automated (MicroScan WalkAway) optical reading of growth inhibition. Connectivity via WalkAway instrument. ## 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 MICroSTREP plus® Panel ([K020691](/device/K020691.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}------------------------------------------------ ## NOV - 9 2006 ### 510(k) Summary Information: | Device Manufacturer: | Dade Behring Inc. | |----------------------|---------------------------------------------------------------------------------------------------------------------| | Contact name: | Shannon Popson, Regulatory Affairs Manager | | Phone/Fax: | 916-374-3330/916-374-3144 | | Date prepared: | October 5, 2006 | | Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | | Trade Name: | MicroScan MICroSTREP plus® Panel | | Intended Use: | To determine bacterial susceptibility to Cefaclor | | Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci,
including Streptococcus pneumoniae | | Predicate device: | MicroScan MICroSTREP plus® Panel (K020691) | ## 510(k) Summary: The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/-1 ℃ in a non-CO2 incubator, and read according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument. The proposed instrument read method for the MicroScan MICroSTREP plus Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus® Panel with Cefaclor on the MicroScan® WalkAway instrument. The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed instrument read method for {1}------------------------------------------------ the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 92.5% for Cefaclor instrument read results compared with the Expected Result. Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefaclor and the WalkAway® instrument. Quality Control testing demonstrated acceptable results for Cefaclor. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972 NOV - 9 2006 Re: k063102 Trade/Device Name: MicroScan MICroSTREP plusio Panel Cefaclor (0.5 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: October 5, 2006 Received: October 10, 2006 Dear Ms. Mende: 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). {3}------------------------------------------------ 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, perrects 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 of 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 tollorities (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.htmil. Sincerely yours. Sally, artin 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 {4}------------------------------------------------ | Indication for Use Statement | | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No.: | K063102
(To be assigned by FDA) | | Device Name: | MicroScan MICroSTREP plus® Panel
Cefaclor (0.5 - 8 mcg/ml) | | Intended Use | To determine bacterial antimicrobial agent susceptibility | | Indications for Use: | The MicroScan MICroSTREP plus® Panel is used to determine
quantitative and/or qualitative antimicrobial agent susceptibility of
colonies grown on solid media of aerobic streptococci, including
Streptococcus pneumoniae . After inoculation, panels are incubated for
20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read
visually according to the Package Insert. Additionally, the panels may
be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read
capability of the antimicrobial Cefaclor, at concentrations of 0.5 to 8
mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Cefaclor susceptibility testing in
this panel are:
Streptococcus pneumoniae | | Prescription Use
X
(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) Fuddie Poole Division Sign-Off Page 1 of Office of In Vitro Diagnostic Device Evaluation and Safety K063/02 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG/K063102](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG/K063102) **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