Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

K153687 · Liofilchem s.r.l. · JWY · Mar 31, 2016 · Microbiology

Device Facts

• Record ID: K153687
• Device Name: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
• Applicant: Liofilchem s.r.l.
• Product Code: JWY · Microbiology
• Decision Date: Mar 31, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscretibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example. Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 us/mL interpreted after 24 hours incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are: Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium

Device Story

Quantitative antimicrobial susceptibility test (AST) system; utilizes specialized paper strips impregnated with predefined vancomycin concentration gradient. Applied to inoculated Mueller Hinton agar; incubation for 24 hours at 35°C. Forms symmetrical inhibition ellipse; MIC value read manually at intersection of ellipse edge and strip. Used in clinical microbiology laboratories by trained personnel. Provides MIC in μg/mL to guide antibiotic therapy selection. Benefits include standardized, quantitative susceptibility determination for non-fastidious and fastidious bacteria.

Clinical Evidence

Performance evaluated using 812 clinical and 76 challenge isolates (S. aureus, S. epidermidis, E. faecalis, E. faecium). Compared to CLSI reference broth microdilution. Combined results showed 99.9% Essential Agreement (EA) and 99.0% Category Agreement (CA). Reproducibility demonstrated ≥95% agreement within one doubling dilution. Observed lower MIC trending for MRSA isolates; addressed via labeling. No clinical sensitivity/specificity studies performed as this is an in vitro diagnostic device.

Technological Characteristics

Specialized paper strip impregnated with a stable concentration gradient of vancomycin (0.016 - 256 µg/mL). Principle of operation is based on diffusion of the antimicrobial agent into agar media to create an inhibition ellipse. Manual reading procedure. Standalone diagnostic device; no software or electronic components.

Indications for Use

Indicated for in vitro determination of antimicrobial susceptibility of non-fastidious Gram-positive bacteria, specifically Staphylococcus aureus, Staphylococcus epidermidis (including methicillin-resistant strains), Enterococcus faecalis, and Enterococcus faecium, to vancomycin.

Regulatory Classification

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

• Liofilchem MIC Test Strip (MTS) (K150868)

Submission Summary (Full Text)

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.

April 1, 2016

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

LIOFILCHEM S.R.L. % LAURA KOETH LABORATORY SPECIALISTS, INC. 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145

Re: K153687

Trade/Device Name: Liofilchem MIC Test Strip (MTS)-Vancomvcin 0.016 -256 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY Dated: December 16, 2015 Received: January 14, 2016

Dear Ms. Koeth:

This letter corrects our substantially equivalent letter of March 31, 2016.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Steven R. Gitterman -S

For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K153687

Device Name

Liofilchem MIC Test Strip (MTS) - Vancomycin 0.016 - 256 ug/mL

Indications for Use (Describe)

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscretibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example. Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 us/mL interpreted after 24 hours incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are:

Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium

| Type of Use (Select one or both, as applicable) | |
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> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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