DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K042157 · Oxoid , Ltd. · JTN · Sep 14, 2004 · Microbiology

Device Facts

• Record ID: K042157
• Device Name: DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
• Applicant: Oxoid , Ltd.
• Product Code: JTN · Microbiology
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Daptomycin these include Staphylococcus aureus (including MRSA), Streptococcus agalactiae, Streptococcus dysagalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible strains only).

Device Story

Oxoid Daptomycin Susceptibility Test Disc is an in vitro diagnostic device used in clinical microbiology laboratories. It consists of paper discs impregnated with a specific concentration of the antibiotic daptomycin. The discs are placed on agar plates inoculated with the patient's bacterial isolate. As the antibiotic diffuses into the agar, it inhibits the growth of susceptible bacteria, creating a zone of inhibition. Laboratory technicians measure the diameter of this zone to determine the susceptibility of the organism to daptomycin. The results assist clinicians in selecting appropriate antibiotic therapy for patients with infections caused by the specified organisms.

Clinical Evidence

No clinical data provided; device performance is established through bench testing of antimicrobial susceptibility using standardized agar diffusion procedures.

Technological Characteristics

Paper-based susceptibility test discs impregnated with daptomycin. Designed for use in agar diffusion (Kirby-Bauer) testing. Standalone laboratory consumable; no software or electronic components.

Indications for Use

Indicated for semi-quantitative susceptibility testing of rapidly growing microorganisms, specifically Staphylococcus aureus (including MRSA), Streptococcus agalactiae, Streptococcus dysagalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible strains only) using agar diffusion methods.

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

Public Health Service

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SEP 1 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k042157 Re:

Trade/Device Name: Oxoid Daptomycin Susceptibility Test Disc Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: August 5, 2004 Received: August 10, 2004

Dear Mr. Hollingsworth:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent as and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. use stated in the encreative to togally in togens )
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered phor to they 20, 2017 11:51 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 r ou may, mererore, mains of the Act include requirements for annual registration, listing of general controls provision 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 It inay be subject to satin additions (CFR), Parts 800 to 895. In addition, FDA can oe found in There announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri brissantes cour device complies with other requirements of the Act mail 1 Drias made a acterimentations administered by other Federal agencies. You must of any I cach statutes and regaranents, including, but not limited to: registration and listing (21 Comply with and the Frequirements 801 and 809); and good manufacturing practice CI K Fart 807), labeling 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) I mis icher will and w you w ough finding of substantial equivalence of your device to a legally promatics notification: "The Profit and 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, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the promotion 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 Four may 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/dsma/dsmamain.html.

Sincerely yours,

Salgado

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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## 510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc Daptomycin

## Indications for Use

510(K) Number : K042157

Oxoid Daptomycin Susceptibility Test Disc Device Name :

Indication for Use :

Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar Alfinincrootal Gaseeparemly Troly growing micro-organisms. For Daptomycin these include unnusion icsi procedure of inprary gromang resus agalactiae, Streptococcus disagalactiae subsp. Stapily to Coccus antous metading Mires () & Prococus faccalis (vancomycin-susceptible strains only).

Prescription Use (21CFR801 subpart D) Over-The-Counter Use (21CFR807 subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics Division Sign-Off

AND/OR

Office of In Vitro Diagnostic Device Evaluation and Safety

cinni KO42157