SENSITITRE SUSCEPTIBILITY PLATES

K141000 · Thermo Fisher Scientific · JWY · Jul 16, 2014 · Microbiology

Device Facts

• Record ID: K141000
• Device Name: SENSITITRE SUSCEPTIBILITY PLATES
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Jul 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

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

Device Story

System performs quantitative antimicrobial susceptibility testing (AST) for non-fastidious Gram-positive organisms. Plates are pre-dosed with antimicrobial agents (Telavancin) and fluorogenic substrates. Bacterial isolates are inoculated into the plates and incubated for 18-24 hours. Bacterial surface enzymes cleave the substrate, releasing a fluorophore. Fluorescence intensity, proportional to bacterial growth, is measured either manually (Vizion) or automatically (ARIS/Autoreader/OptiRead). Results determine the Minimum Inhibitory Concentration (MIC). Healthcare providers use these results to guide antibiotic therapy decisions. The system benefits patients by providing susceptibility data to inform appropriate antimicrobial treatment.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to demonstrate performance equivalence for the susceptibility test plate with Telavancin.

Technological Characteristics

Multi-well plastic microtiter plates containing dried antimicrobial agents and fluorogenic substrates. Fluorescence-based detection of bacterial growth via surface enzyme activity. Dimensions: 96-well plate format. Instrumentation: Autoinoculator, Optiread, Vizion, Nephelometer. Connectivity: Automated reader integration. Sterilization: Not specified.

Indications for Use

Indicated for clinical susceptibility testing of non-fastidious Gram-positive isolates, specifically Staphylococcus aureus (including methicillin-resistant isolates) and Enterococcus faecalis.

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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 16, 2014

THERMOFISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS I THERMO FISHER WAY OAK WOOD VILLAGE OH 44146

Re: K141000

Trade/Device Name: The Sensititre 18-24 hour MIC Susceptibility System Susceptibility Test Plate with Telavancin (0.0005-2ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Requlatory Class: II Product Code: JWY, LRG, LTT, LTW Dated: July 2. 2014 Received: July 3. 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 mav. 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 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 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/ResourcesforYou/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,

# Sally A Hojvat -S

Sally A. 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) K141000

## Device Name

The Sensititre® 18 - 24 hour MIC Susceptibility System Susceptibility Test Plate with Telavancin (0.0005-20g/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 5 IV(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititee 18 - 24 hour MCC panel for terfeirences of on positive isolates.

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

Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Ribhi Shawar -S 2014.07.14 15:55:23 -04

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