Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL

K193024 · Thermo Fisher Scientific · JWY · Jan 8, 2020 · Microbiology

Device Facts

• Record ID: K193024
• Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Jan 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System is an in vitro diagnostic product for clinical use. It is intended for the determination of susceptibility to antimicrobial agents. The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System is indicated for the determination of susceptibility to antimicrobial agents by broth microdilution methods. The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16 µg/mL is indicated for the determination of susceptibility to Lefamulin against Haemophilus influenzae and Streptococcus pneumoniae.

Device Story

Sensititre system performs quantitative antimicrobial susceptibility testing (AST) via broth microdilution. Multi-well plastic microtiter plates contain dried, stabilized antimicrobial agents (Lefamulin) in double dilutions. Plates are inoculated with bacterial suspensions using the Sensititre AIM autoinoculator, sealed, and incubated for 20-24 hours. Growth is detected via visual inspection using the VIZION digital viewing device or automated fluorescence detection using the OptiRead system. OptiRead monitors surface enzyme activity by detecting fluorescent products generated from fluorogenic substrates. The MIC is the lowest concentration inhibiting bacterial growth. Results assist clinicians in determining appropriate antimicrobial therapy. System is intended for laboratory use by trained personnel.

Clinical Evidence

Bench testing only. Performance evaluated using 200 clinical and 50 challenge S. pneumoniae isolates, and 393 clinical and 50 challenge H. influenzae isolates. Compared against CLSI broth microdilution reference method. For S. pneumoniae (VIZION), EA was 99.2% and CA 98.4%. For S. pneumoniae (OptiRead), EA was 98.8% and CA 98.8%. For H. influenzae (VIZION), EA was 98.9% and CA 94.8%. Adjusted major error rate for H. influenzae was 0.2%. Adjusted very major error rate for S. pneumoniae was 0%.

Technological Characteristics

Multi-well microtiter plates; dried, stabilized antimicrobial agents. Sensing principle: visual (VIZION) or fluorescence-based enzymatic activity detection (OptiRead). Energy source: electrical (readers). Connectivity: standalone/networked. Inoculation: Sensititre AIM autoinoculator. Incubation: 34–36 °C. Software: automated reading/interpretation.

Indications for Use

Indicated for the determination of antimicrobial susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to the antibiotic Lefamulin (dilution range 0.008-16 µg/mL) using broth microdilution methods in a clinical laboratory setting.

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

• Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System (K190275)

Submission Summary (Full Text)

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January 8, 2020

Thermo Fisher Scientific Cynthia Knapp Director of AST/Pharma R&D One Thermo Fisher Way Oakwood Village, Ohio 44146

Re: K193024

Trade/Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16 µg/mL

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: October 24, 2019 Received: October 30, 2019

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure