VERSATREK

K032306 · Trek Diagnostic Systems, Inc. · MDB · Aug 22, 2003 · Microbiology

Device Facts

• Record ID: K032306
• Device Name: VERSATREK
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: MDB · Microbiology
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Intended Use

VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids. VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens. Organism identification may be determined using nucleic acid probes (AccuProbe®) . The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.

Device Story

VersaTREK is an automated microbial growth monitoring system; used in clinical laboratories for culture and recovery of microorganisms from patient samples; also supports mycobacteria susceptibility testing. System monitors growth via detection of metabolic activity in culture media; provides automated alerts for positive cultures. Healthcare providers use results to identify pathogens and guide antimicrobial therapy; facilitates timely diagnosis of infections; enables targeted treatment for mycobacterial infections.

Clinical Evidence

No clinical data provided in the summary; device relies on substantial equivalence to previously cleared systems for microbial growth monitoring and susceptibility testing.

Technological Characteristics

Automated microbial growth monitor; utilizes metabolic detection principle for culture recovery; supports nucleic acid probe identification and qualitative susceptibility testing; intended for laboratory use.

Indications for Use

Indicated for cultivation and recovery of microorganisms (bacteria, yeasts, mycobacteria) from blood, sterile body fluids, and clinical specimens; qualitative susceptibility testing of M. tuberculosis isolates to Rifampin, Ethambutol, and Isoniazid.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a stylized drawing of an eagle or bird in flight. The bird is composed of thick, black lines that create a sense of movement and dynamism. The bird is surrounded by a dotted circle, which adds a sense of enclosure and focus to the image.

Public Health Service

AUG 2 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nadine M. Sullivan, Ph.D. Chief Science Officer TREK Diagnostic Systems 982 Keynote Circle, Suite 6 Cleveland, OH 44131

Re: k032306

> Trade/Device Name: VERSATREK Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: July 17, 2003 Received: July 25, 2003

Dear Dr. Sullivan:

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 either class II (Special Controls) or class III (PMA), 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

## Page 2 -

This letter will allow you to begin marketing your device as described in your 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATIONS FOR USE STATEMENT VersaTREK Instrument

Blood Culture System (K921637/A): VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.

Myco Detection (K972756): VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens.

Myco modification-Organism Identification (KK972772): Organism identification may be determined using nucleic acid probes (AccuProbe®) .

Mvcobacterium tuberculosis susceptibility testing (K972772): The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Salafanos 8/20/03
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko32306

Prescription Use (Per 21CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)