Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

K153569 · Liofilchem s.r.l. · JWY · Jun 22, 2016 · Microbiology

Device Facts

• Record ID: K153569
• Device Name: Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
• Applicant: Liofilchem s.r.l.
• Product Code: JWY · Microbiology
• Decision Date: Jun 22, 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 susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). 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 (MIC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The purpose of the 510(k) is specifically for the dalbavancin MTS at concentrations of 0.002-32 ug/mL interpreted after 16-20 hours incubation. Dalbavancin has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label: Staphylococcus aureus (including methicillin resistant strains) Enterococcus faecalis (vancomycin susceptible strains)

Device Story

Liofilchem MIC Test Strip (MTS) is a quantitative diagnostic tool for determining minimum inhibitory concentration (MIC) of antimicrobial agents. Device consists of specialized paper strip impregnated with pre-defined concentration gradient of Dalbavancin (0.002-32 µg/mL). Used in clinical microbiology laboratories by trained personnel. Procedure involves placing strip on inoculated agar media, followed by 16-20 hours of incubation. MIC is determined via manual visual inspection of the inhibition ellipse formed around the strip. Results assist healthcare providers in selecting appropriate antibiotic therapy for patients with bacterial infections. Benefits include standardized, quantitative susceptibility data to guide clinical decision-making.

Clinical Evidence

No clinical data provided. Performance established via bench testing comparing MIC results to reference methods for specified bacterial strains.

Technological Characteristics

High-quality paper strip impregnated with dalbavancin gradient (0.002–32 µg/mL). Manual reading of inhibition ellipse on Mueller Hinton agar. Incubation 35°C ± 2°C for 16–20 hours. No electronic components or software; purely manual, growth-based detection.

Indications for Use

Indicated for in vitro determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. Specifically for dalbavancin (0.002–32 µg/mL) against Staphylococcus aureus (including MRSA) and Enterococcus faecalis (vancomycin-susceptible).

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.

Submission Summary (Full Text)

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Public Health Service

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

June 22, 2016

LIOFILCHEM s.r.l. C/O LAURA KOETH LABORATORY SPECIALISTS, INC. 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145

Re: K153569

Trade/Device Name: Liofilchem MIC Test Strip (MTS) - Dalbavancin at 0.002 - 32 µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: April 15, 2016 Received: April 20, 2016

Dear Ms. Koeth:

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

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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,

# Ribhi Shawar -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) K153569

Device Name

Liofilchem MIC Test Strip (MTS) Dalbavancin 0.002-32 ug/mL

### Indications for Use (Describe)

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). 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 (MIC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of the 510(k) is specifically for the dalbavancin MTS at concentrations of 0.002-32 ug/mL interpreted after 16-20 hours incubation.

Dalbavancin has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Staphylococcus aureus (including methicillin resistant strains) Enterococcus faecalis (vancomycin susceptible strains)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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