Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL

K183324 · Thermo Fisher Scientific · JWY · Feb 15, 2019 · Microbiology

Device Facts

• Record ID: K183324
• Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Feb 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species.

Device Story

Sensititre MIC Susceptibility panels are multi-well microtiter plates containing dried, stabilized antimicrobials; miniaturized broth dilution method. Device takes bacterial isolates as input; plates are inoculated using Sensititre AIM autoinoculator; incubated at 34-36°C for 20-24 hours. Growth detection via VIZION digital viewing device (manual) or OptiRead automated reader (fluorescence-based). OptiRead monitors surface enzyme activity using fluorogenic substrates; fluorescence intensity correlates to bacterial growth. Output is Minimum Inhibitory Concentration (MIC) value. Used in clinical microbiology laboratories by technicians. Results assist clinicians in determining antimicrobial susceptibility for patient treatment decisions.

Clinical Evidence

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

Technological Characteristics

Microbroth dilution susceptibility test system. Consists of multi-well plates containing dehydrated antimicrobial agent (Omadacycline) in specific concentration ranges. Designed for 20-24 hour incubation. Operates via standard in vitro diagnostic laboratory procedures for bacterial growth inhibition measurement.

Indications for Use

Indicated for clinical susceptibility testing of fastidious isolates, specifically Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus anginosus group (S. anginosus, S. intermedius, S. constellatus), and Streptococcus pyogenes, using Omadacycline.

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/Streptococcus pneumoniae (HP) MIC Plates (K040846)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

February 15, 2019

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

Re: K183324

Trade/Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL

Regulation Number: 21 CFR 866.1640

Regulation Name: Antimicrobial susceptibility test powder

Regulatory Class: Class II

Product Code: JWY, LRG, LTT

Dated: November 28, 2018

Received: November 30, 2018

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K183324 - Cynthia Knapp
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801 and Part 809); medical device reporting (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 (QS) 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 medical devices and radiation-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,

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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K183324 | |
| Device Name Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 μg/mL | |
| Indications for Use (Describe) The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 μg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |