Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL

K182797 · Thermo Fisher Scientific · JWY · Nov 30, 2018 · Microbiology

Device Facts

• Record ID: K182797
• Device Name: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre MIC and Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative isolates, comprising of Enterobacteriaceae, Pseudomonas aeruginosa, and other non-Enterobacteriaceae and of non-fastidious Gram positive isolates, comprising of Staphylococcus spp., Enterococcus spp., and Beta haemolytic Streptococci other than S. pneumoniae.

Device Story

Sensititre 18–24 hour MIC or Breakpoint Susceptibility System uses multi-well plastic micro-titer plates dosed with dried, stabilized antimicrobials; miniaturized broth dilution method. Inoculated plates are incubated (34–36°C) for 18–24 hours. Bacterial growth is detected via surface enzyme activity using a fluorogenic substrate; fluorescence intensity correlates with growth. Plates are read using either the VIZION digital viewing device (manual selection) or the OptiRead automated reader (fluorescence detection). Used in clinical microbiology laboratories by technicians. Output is the Minimum Inhibitory Concentration (MIC) and interpretive category (Susceptible). Results assist clinicians in selecting appropriate antimicrobial therapy for bacterial infections. Benefits include standardized, quantitative susceptibility testing to guide antibiotic treatment.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics of the antimicrobial susceptibility test system.

Technological Characteristics

Multi-well plastic micro-titer plates; dried, stabilized antimicrobial agents. Sensing principle: fluorescence detection of bacterial surface enzyme activity. Dimensions: 96-well format. Connectivity: standalone (VIZION) or instrument-integrated (OptiRead). Sterilization: not specified. Software: automated reading algorithm for fluorescence quantification.

Indications for Use

Indicated for use as an antimicrobial susceptibility test system for determining the minimum inhibitory concentration (MIC) or breakpoint of Eravacycline in the dilution range of 0.008 - 16 ug/mL.

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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November 30, 2018

Thermo Fisher Scientific Cynthia Knapp Director of AST/Pharma R&D 1 Thermo Fisher Way Oakwood Village, Ohio 44014-6

Re: K182797

Trade/Device Name: Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008 - 16 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: September 28, 2018 Received: October 1, 2018

Dear Cynthia Knapp:

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/cdrh/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

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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 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 (OS) 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,

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)

Device Name

Indications for Use (Describe)

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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