ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K070262 · Oxoid , Ltd. · JTN · Mar 14, 2007 · Microbiology

Device Facts

• Record ID: K070262
• Device Name: ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
• Applicant: Oxoid , Ltd.
• Product Code: JTN · Microbiology
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Oxoid Antimicrobial Susceptibility Test Discs are used in the agar diffusion test method for in vitro susceptibility testing. This semi-quantitative method is for use with rapidly growing organisms including Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes and some streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae, and Streptococcus pneumoniae.

Device Story

Ertapenem Antimicrobial Susceptibility Test Discs consist of 6 mm absorbent paper discs impregnated with 10 µg/mL of Ertapenem. Used in clinical microbiology laboratories for in vitro susceptibility testing via the Kirby-Bauer agar diffusion method. Laboratory personnel inoculate Mueller-Hinton agar with bacterial colonies standardized to a 0.5 McFarland turbidity; place discs onto the agar surface; and incubate. Following incubation, the technician measures the diameter of the zone of inhibition around the disc. These measurements are compared against established interpretive criteria to categorize the organism as susceptible, intermediate, or resistant. This process assists clinicians in selecting appropriate antibiotic therapy for patients by identifying bacterial susceptibility to Ertapenem.

Clinical Evidence

No clinical data. Performance characteristics were established based on interpretive criteria and quality control ranges provided by the FDA/CDER-approved pharmaceutical package insert for Ertapenem.

Technological Characteristics

Paper-based antimicrobial susceptibility test discs impregnated with ertapenem. Operates via passive diffusion in agar medium. Standardized form factor for use in manual or automated agar diffusion systems. No electronic components, software, or energy sources.

Indications for Use

Indicated for semi-quantitative susceptibility testing of rapidly growing microorganisms including S. aureus (methicillin-susceptible), S. agalactiae, S. pneumoniae (penicillin-susceptible), S. pyogenes, E. coli, H. influenzae (beta-lactamase negative), K. pneumoniae, M. catarrhalis, and P. mirabilis using agar diffusion.

Regulatory Classification

Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road, Basingstoke Hants RG24 8PW England

MAR 1 4 2007

Re: k070262

> Trade/Device Name: Ertapenem Antimicrobial Susceptibility Test Disc Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: January 2, 2007 Received: January 26, 2007

Dear Mr. Hollingsworth:

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).

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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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally, a story

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

510(k) Number (if known): K070262

Device Name: Ertapenem Antimicrobial Susceptibility Test Disc

Indications For Use:

Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Ertapenem these include: Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin susceptible isolates only), Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae (Beta-lactamase negative isolates only), Klebsiella pneumoniae, Moraxella catarrhalis, and Proteus mirabilis.

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)

Ludde W. Rode
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070212