Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)

K150556 · Thermo Fisher Scientific · JWY · Aug 28, 2015 · Microbiology

Device Facts

• Record ID: K150556
• Device Name: Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Aug 28, 2015
• 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 non-fastidious Gram positive isolates, comprising of Staphylococcus spp., Enterococcus spp., and Beta hemolytic Streptococci other than S. pneumoniae.

Device Story

Sensititre MIC Susceptibility plates are multi-well plastic micro-titer plates containing dried, stabilized antimicrobials; used for quantitative/qualitative antimicrobial susceptibility testing (AST). Device functions as a micro-broth dilution method. Input: bacterial isolates from culture. Process: inoculation of plates, incubation at 34-36°C for 18-24 hours, and detection of bacterial growth. Growth detection via visual inspection or automated fluorescence-based monitoring of surface enzyme activity. Output: Minimum Inhibitory Concentration (MIC) values and interpretative criteria (S, I, R). Used in clinical laboratories; operated by technicians. Results assist healthcare providers in selecting appropriate antimicrobial therapy for patients with non-fastidious Gram-negative infections.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing of antimicrobial susceptibility performance.

Technological Characteristics

Multi-well plastic micro-titer plates; dried, stabilized antimicrobial agents. Sensing principle: fluorescence detection of bacterial surface enzyme activity (cleavage of fluorogenic substrate). Energy source: electrical (for readers). Connectivity: standalone or networked (AutoReader/OptiRead/ARIS). Software: automated analysis of fluorescence intensity. Sterilization: not specified.

Indications for Use

Indicated for clinical susceptibility testing of non-fastidious Gram-negative isolates (Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa) using Ceftolozane/Tazobactam in the dilution range of 0.03/4 - 64/4 µg/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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 28, 2015

THERMO FISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44014-6

Re: K150556

Trade/Device Name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftolozane/Tazobactam in the dilution range of 0.03/4 - 64/4 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LRG, LTT Dated: July 20, 2015 Received: July 24, 2015

Dear Ms. 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. 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,

## 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) K150556

Device Name

The Sensititie 18-24 hour MC or Breakpoint System with Ceftolozane/Tazobactam in the dilution range of 0.03/4 -64/4 ug/mL

Indications for Use (Describe)

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510/k) is for Ceftolozane Tazobactam in the dilution range of 0.03/4 - 64/4 ug/mL for testing non-fastidious gram negative organisms on the Sensititre 18-24 hour MIC panel.

The approved primary "Indications for Use" and clinical significance for non-fastidious Gram negative isolates: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

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

| <div> <span style="font-size:10pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size:10pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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| | Over-The-Counter Use (21 CFR 801 Subpart C)

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