The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)

K143526 · Thermo Fisher Scientific · JWY · Mar 5, 2015 · Microbiology

Device Facts

• Record ID: K143526
• Device Name: The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Mar 5, 2015
• 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 HP MIC Susceptibility plate is an in vitro diagnostic device used in clinical laboratories for antimicrobial susceptibility testing. It utilizes microbroth dilution to determine the Minimum Inhibitory Concentration (MIC) of Oritavancin against fastidious Streptococcus species. The device consists of plates containing specific concentrations of the antimicrobial agent. Laboratory technicians inoculate the plates with patient isolates; after incubation, growth is observed to determine the MIC. The resulting MIC value assists clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. The device provides standardized, quantitative susceptibility data to guide clinical decision-making and improve patient outcomes.

Clinical Evidence

Clinical study conducted at three sites using 411 clinical and 65 challenge Streptococcus spp. isolates. Performance evaluated against CLSI broth microdilution reference method. Combined Essential Agreement (EA) was 94.7% (automated) and 94.3% (manual). Category Agreement (CA) was 95.4% (automated) and 95.6% (manual). A downward MIC trend was observed; labeling includes limitations for isolates yielding 0.25 µg/mL MIC due to potential for very major errors (false susceptible).

Technological Characteristics

Multi-well plastic microtiter plate; contains doubling dilutions of antimicrobial agents and fluorogenic substrate. Sensing principle: fluorescence detection of bacterial surface enzyme activity. Energy source: electrical (for automated readers). Connectivity: standalone or networked (ARIS/OptiRead). Software: automated interpretation of fluorescence intensity. Sterilization: not specified.

Indications for Use

Indicated for clinical susceptibility testing of fastidious isolates, specifically Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (S. anginosus, S. intermedius, and S. constellatus).

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

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

March 5, 2015

Re: K143526

Trade/Device Name: The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/mL

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY, LRG, LTT, LTW Dated: December 10, 2014 Received: December 12, 2014

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,

Uwe Scherf –S for

Sally Hojvat, M.Sc., PhD. 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

## Indications for Use

510(k) Number (if known) k143526

Device Name

The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/ml

Indications for Use (Describe)

The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8ug/ml to the Sensitire HP MIC Susceptibility plate for testing Streptococcus spp.

The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus dysgalactia Streptococcus anginosus

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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