SENSITITRE OPTIREAD

K110583 · Trek Diagnostic Systems, Ltd. · LRG · Sep 22, 2011 · Microbiology

Device Facts

• Record ID: K110583
• Device Name: SENSITITRE OPTIREAD
• Applicant: Trek Diagnostic Systems, Ltd.
• Product Code: LRG · Microbiology
• Decision Date: Sep 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

Device Story

OptiRead™ is a fluorescence-based detection instrument for reading Sensititre® MIC or BP Susceptibility plates. Used in clinical laboratory settings to support antimicrobial susceptibility testing. Operation initiated via SWIN software; instrument reads fluorescence values from susceptibility plates; data transferred back to SWIN software for result generation. Assists healthcare providers in determining bacterial susceptibility to antibiotics, informing clinical treatment decisions for patients with non-fastidious Gram-negative infections.

Clinical Evidence

No clinical data provided; device is an automated reader for established in vitro diagnostic susceptibility test systems.

Technological Characteristics

Fluorescence-based fluorimeter; 360nm LED excitation source; photodiode signal detection. Dimensions: 357.5mm x 264mm x 188.5mm. Connectivity: External serial port for calibration; PC-based data transfer. Software: SWIN. Calibration: Internal solid-state block and plate-specific calibration wells. Sterilization: Not applicable (instrument).

Indications for Use

Indicated for clinical susceptibility testing of non-fastidious Gram negative organisms using the Sensititre® MIC or BP Susceptibility Test System. For prescription use only.

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 Mail Center-WO66-G609 Silver Spring, MD 20993-0002

TREK Diagnostics Systems. Ltd. C/o Cindy Knapp Director of US regulatory and Global Clinical Affairs 982 Keynote Circle, Suite 6 Cleveland OH 44131

SEP 22 2011

Re: K110583

Trade/Device Name: OptiReadTM Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LRG Dated: September 16, 2011 Received: September 19, 2011

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 thai 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); and good manufacturing practice

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requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in vour Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Fredalite Tu. Poole, MC

Sally Hojvat. P Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT Sensititre® OptiRead™

510(k) Number (if known):

Device Name: The Sensititre® OptiRead™

Indications for Use:

The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

NOTE: Please refer to the Sensititre @ 18-24 hour MIC or Breakpoint Susceptibility System package insert or operator's manual for additional instructions, limitations and references.

## This 510(k) is for the addition of: "Sensititre® OptiRead™

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rueddle lu. Poole
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110583