ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING

K972772 · Trek Diagnostic Systems, Inc. · MJA · Jul 13, 1999 · Microbiology

Device Facts

• Record ID: K972772
• Device Name: ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: MJA · Microbiology
• Decision Date: Jul 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.

Device Story

Automated system for microbial growth detection and mycobacterial susceptibility testing; inputs include blood, sterile body fluids, or mycobacterial samples; utilizes ESP Myco seed bottles or agar-grown colonies as inoculum; system monitors growth and performs susceptibility testing against specific antibiotics (rifampin, isoniazid, ethambutol); used in clinical laboratory settings by trained personnel; output provides microbial growth status and susceptibility results to assist clinicians in selecting appropriate antimicrobial therapy; benefits include standardized, automated testing for mycobacterial infections.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device performance specifications.

Technological Characteristics

Automated microbial detection and susceptibility testing system; utilizes ESP Myco seed bottles or McFarland No. 1 equivalent cell suspensions; designed for clinical laboratory use; regulatory class II.

Indications for Use

Indicated for detection of microbial growth in blood and sterile body fluids, and detection of mycobacteria from various sources. Also indicated for susceptibility testing of Mycobacterium tuberculosis against rifampin, isoniazid, and ethambutol using ESP Myco seed bottles or McFarland No. 1 equivalent cell suspensions.

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 9200 Corporate Boulevard Rockville MD 20850

JUL 13 1999

Nadine M. Sullivan, Ph.D. Chief Science Officer TREK Diagnostic Systems, Inc. 210 Business Park Drive Sun Prairie, WI 53590

Re: K972772

Trade Name: ESP Culture System II - Myco Susceptibility Testing Regulatory Class: II Product Code: MJA Dated: June 29, 1999 Received: July 1, 1999

Dear Dr. Sullivan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K972772 Device Name: ESP Culture System II

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Indications For Use:

The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

| | <i>Woody Dubois</i> |
|-----------------------------------------|---------------------|
| | (Division Sign-Off) |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972772 |

| Prescription Use <b>X</b> | OR | Over-The Counter Use ______ |
|---------------------------|----|-----------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

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