← Product Code [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY) · K020748 # ETEST ERTAPENEM (K020748) _Ab Biodisk · JWY · Apr 29, 2002 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K020748 ## Device Facts - **Applicant:** Ab Biodisk - **Product Code:** [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY.md) - **Decision Date:** Apr 29, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1640 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as S. pneumoniae, Neisseria gonorrhoeae and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) of antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Ertapenem in the range of 0.002-32 µg/mL for E. coli, K. pneumoniae, S. aureus (methicillin susceptible strains), S. pneumoniae (penicillin susceptible strains), S. agalactiae, S. pyogenes, H. influenzae (β-lactamase negative and positive strains), Bacteroides spp, Prevotella bivia, P. asaccharolytica and Peptostreptococcus spp. ## Device Story Etest is a quantitative antimicrobial susceptibility testing device; consists of a predefined antibiotic gradient on a plastic strip; used on agar media; determines minimum inhibitory concentration (MIC) of Ertapenem; used in clinical laboratories by trained personnel; provides MIC values to clinicians to guide antibiotic therapy; aids in managing bacterial infections. ## Clinical Evidence No clinical data provided; device performance is based on bench testing for MIC determination. ## Technological Characteristics Quantitative antimicrobial susceptibility test; predefined antibiotic gradient on a plastic strip; agar diffusion method; overnight incubation; manual interpretation of MIC values. ## 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. ## 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human figures. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Anne Bolmström President/Managing Director AB Biodisk Dalvägen 10 S-169 56 Solna Sweden ## APR 2 9 2002 k020748 Re: Trade/Device Name: Etest® Ertapenem Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: February 28, 2002 Received: March 7, 2002 Dear Ms. Bolmström: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreatives of the enactment date of the Medical Device Amendments, or to conninered prof to that 20, 1977, is occordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmodel Ace (110) and the device, subject to the general controls provisions of the Act. The r ou may, ateres, mains of the Act include requirements for annual registration, listing of general controls proficituring 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 may or babyee to bases as assist as a subtions, Title 21, Parts 800 to 898. 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 r rease of as made a determination that your device complies with other requirements of the Act that i Dr Haral statutes and regulations administered by other Federal agencies. You must or uny I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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, Steven Butman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1 of 1 ## KO20748 Device Name: Etest® Ertapenem 510(k) Number (if known): ## Indications For Use: For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both Elest is a qualificanve technique for the aerobic bacteria, such as Enterobacteriaceae, non-lastidious Gram negative and Enterococcus species and fastidious bacteria, such as i seudomonas, Staphylococcus and Enters, Conococcus and Haemophilus species. The system anacrobes, I heambeooceas, or specient which is used to determine the minimum inhibitory comprises a predemed antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Ertapenem in the range of 1115 Lest 310(n) apprisation in pneumoniae, S. aureus (methicillin susceptible strains), S. pneumoniae (penicillin susceptible strains), S. agalactiae, S. pyogenes, H. influenzae (βpheamomae (ptive strains), Bacteroides spp, Prevotella bivia, P. asaccharolytica and Peptostreptococcus spp. (Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use scription Use - 21 CFR 801.109) (Optional Format 1-2-96) fueddin. Pooli. (Division Sign-Off) Division of Clinical Labor 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K020748](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K020748) **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