MTS Omadacycline 0.002-32 µg/mL

K182922 · Liofilchem s.r.l. · JWY · Dec 14, 2018 · Microbiology

Device Facts

• Record ID: K182922
• Device Name: MTS Omadacycline 0.002-32 µg/mL
• Applicant: Liofilchem s.r.l.
• Product Code: JWY · Microbiology
• Decision Date: Dec 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Liofilchem® MTS™ (MIC Test Strip) Omadacycline 0.002-32 ug/mL is a quantiative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine thilotiory concentration (MC) in ug/mL of antimicrobial agents against baceria as tested on agar media using overnight incubation and manual reading procedures. The MTSTM Omadacycline at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation. MTS™ Omadacycline can be used to determine the MC of ornadacycline against the following bacteria. Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Omadacycline has been shown to be active in vitro only against the non-fastilous bacteria listed below according to the FDA drug approved label: Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca

Device Story

MTS Omadacycline is a quantitative antimicrobial susceptibility test (AST) strip. Device consists of specialized paper impregnated with a predefined concentration gradient (0.002-32 µg/mL) of Omadacycline. Used in clinical microbiology laboratories by trained personnel. Strip is placed on inoculated agar media; incubated for 16-20 hours. Antimicrobial agent diffuses into agar, creating a concentration gradient. After incubation, the Minimum Inhibitory Concentration (MIC) is determined by observing the point of intersection between the bacterial growth inhibition ellipse and the strip. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. Benefits include standardized, quantitative susceptibility data for specific pathogens.

Clinical Evidence

Bench testing only. Performance evaluated by comparing MIC results of the MTS Omadacycline strip against a reference broth microdilution method. Testing included clinical and challenge isolates of the specified Gram-positive and Gram-negative bacterial species. Results demonstrated essential agreement and categorical agreement within acceptable FDA criteria.

Technological Characteristics

Specialized paper strip impregnated with omadacycline gradient (0.002-32 µg/mL). Manual reading of inhibition ellipse on Mueller Hinton agar. Incubation: 35±2°C for 16-20 hours. No electronic components or software; purely manual, physical test system.

Indications for Use

Indicated for in vitro antimicrobial susceptibility testing of specific Gram-positive (S. aureus, S. lugdunensis, E. faecalis, E. faecium) and Gram-negative (E. cloacae, K. pneumoniae, E. coli, C. freundii, C. koseri, K. aerogenes, K. oxytoca) bacteria to Omadacycline. For prescription use.

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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December 14, 2018

Liofilchem s. r. l. % Laura Koeth President Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145

Re: K182922

Trade/Device Name: MTS Omadacycline 0.002-32 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: October 18, 2018 Received: October 19, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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) K182922

Device Name MTSTM Omadacycline 0.002-32 µg/mL

#### Indications for Use (Describe)

The Liofilchem® MTS™ (MIC Test Strip) Omadacycline 0.002-32 ug/mL is a quantiative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine thilotiory concentration (MC) in ug/mL of antimicrobial agents against baceria as tested on agar media using overnight incubation and manual reading procedures.

The MTSTM Omadacycline at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation.

MTS™ Omadacycline can be used to determine the MC of ornadacycline against the following bacteria. Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis

Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae

Omadacycline has been shown to be active in vitro only against the non-fastilous bacteria listed below according to the FDA drug approved label:

#### Gram-Positive bacteria

Enterococcus faecium (vancomycin-susceptible and -resistant isolates)

Gram-Negative bacteria Escherichia coli Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca

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

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

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