The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL

K172274 · Thermo Fisher Scientific · JWY · Aug 30, 2017 · Microbiology

Device Facts

• Record ID: K172274
• Device Name: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Aug 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species.

Device Story

Sensititre 20-24 hour MIC system uses multiwell plastic microtiter plates pre-dosed with dried, stabilized antimicrobial agents. Device performs in vitro broth microdilution susceptibility testing. Clinical laboratory personnel inoculate plates with bacterial isolates using Sensititre AIM autoinoculator; plates are incubated at 34-36°C for 20-24 hours. Bacterial growth is assessed via manual digital viewing (VIZION) or automated fluorescence-based detection (OptiRead). OptiRead monitors surface enzyme activity using fluorogenic substrates; fluorescence intensity correlates with bacterial growth. Output is the Minimum Inhibitory Concentration (MIC) and interpretive category (S, I, R). Results assist clinicians in selecting appropriate antibiotic therapy for fastidious Streptococcus infections. Performance is unknown for specific resistance mechanisms (QRDRs, efflux).

Clinical Evidence

Performance evaluated using 317 combined clinical (258) and challenge (59) Streptococcus isolates (S. pyogenes, S. agalactiae, S. anginosus). Testing compared Sensititre results (VIZION and OptiRead) against CLSI reference broth microdilution. Combined EA was 99.7% (VIZION) and 99.1% (OptiRead); CA was 100% (VIZION) and 99.1% (OptiRead). Reproducibility >95%. MIC trends noted for S. pyogenes (one dilution higher) and S. agalactiae (one dilution lower on OptiRead).

Technological Characteristics

Microbroth dilution susceptibility system. Consists of multi-well plates containing dehydrated antimicrobial agents (Delafloxacin). Operates via colorimetric or fluorometric growth detection (depending on specific Sensititre configuration). Standardized for 20-24 hour incubation. Designed for use in clinical laboratory environments.

Indications for Use

Indicated for in vitro clinical susceptibility testing of fastidious Streptococcus spp. isolates, specifically Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group, using the Sensititre 20-24 hour system.

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 Haemophilus influenzae/Streptococcus pneumoniae MIC Susceptibility Plate, Clindamycin (K140985)

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" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads suggesting community and support.

August 30, 2017

Public Health Service

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

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

Re: K172274

Trade/Device Name: The Sensititre 20-24 Hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LRG, LTT Dated: July 27, 2017 Received: July 28, 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 (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

### 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) K172274

#### Device Name

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8 ug/ml .

#### Indications for Use (Describe)

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp. on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.

The approved primary "Indications for Use" and clinical significance for fastidious Streptococcus spp. isolates: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp.

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

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

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