The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL

K171870 · Thermo Fisher Scientific · JWY · Aug 1, 2017 · Microbiology

Device Facts

• Record ID: K171870
• Device Name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Aug 1, 2017
• 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 system; multi-well plastic micro-titer plates containing dried, stabilized antimicrobials; micro-version of broth dilution method. Clinical lab use; requires Sensititre AIM autoinoculator for sample preparation; plates incubated 18-24 hours. Growth detection via VIZION digital viewing device (video camera/touch screen) or OptiRead automated reader (fluorescence technology). OptiRead detects bacterial growth by monitoring surface enzyme activity; fluorogenic substrate cleavage releases fluorescence proportional to growth. Output: Minimum Inhibitory Concentration (MIC) and interpretive criteria (S, I, R). Healthcare providers use MIC results to guide antimicrobial therapy decisions for non-fastidious Gram-positive infections.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the Sensititre system's MIC results for Delafloxacin against a reference broth microdilution method. Testing included clinical isolates of Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus lugdunensis, and Enterococcus faecalis. Results demonstrated essential agreement and categorical agreement within acceptable FDA criteria for antimicrobial susceptibility testing devices.

Technological Characteristics

Microbroth dilution susceptibility testing system. Consists of multi-well plates containing dehydrated antimicrobial agent (Delafloxacin) in 0.0005-8 ug/ml range. Operates via visual or automated growth detection after 18-24 hour incubation. Designed for non-fastidious Gram-positive organisms. Standardized laboratory equipment.

Indications for Use

Indicated for in vitro clinical susceptibility testing of non-fastidious Gram-positive organisms, specifically Staphylococcus aureus (MRSA/MSSA), Staphylococcus haemolyticus, Staphylococcus lugdunensis, and Enterococcus faecalis, using Delafloxacin in the 0.0005-8 ug/ml range.

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 18-24 Hour MIC or Breakpoint Susceptibility System (K171870)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 1, 2017

THERMOFISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44146

Re: K171870

Trade/Device Name: The Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 - 8 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LRG, LTT Dated: June 21, 2017 Received: June 22, 2017

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 (OS) 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| 510(k) Number ( <i>if known</i> ) | K171870 |
| Device Name | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005-8 ug/ml. |
| Indications for Use ( <i>Describe</i> ) | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an <i>in vitro</i> diagnostic product for clinical susceptibility testing of non fastidious isolates. |

This 510(k) is for Delafloxacin the dilution range of 0.0005-8 ug/ml for testing non-fastidious gram positive organisms on
the Sensititre 18 - 24 hour MIC panel.

The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates:

Staphylococcus aureus (including MRSA and MSSA)

Staphylococcus haemolyticus

Staphylococcus lugdunensis

Enterococcus faecalis

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| | <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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