SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)

K983244 · Trek Diagnostic Systems, Inc. · JTW · Nov 30, 1998 · Microbiology

Device Facts

• Record ID: K983244
• Device Name: SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JTW · Microbiology
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Intended Use

The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.

Device Story

Sensititre 18-24 Hour Susceptibility system; in vitro diagnostic device for clinical microbiology laboratories. Used by laboratory technicians to determine Minimum Inhibitory Concentrations (MIC) or breakpoint susceptibility of gram-negative and gram-positive organisms. Device consists of susceptibility plates containing antimicrobial agents, including Meropenem. Samples (bacterial isolates) are inoculated into plates; incubated for 18-24 hours. Growth/inhibition patterns are observed to determine susceptibility. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing performance of the Sensititre system with the addition of Meropenem for susceptibility testing of gram-negative isolates.

Technological Characteristics

In vitro diagnostic susceptibility test panel. Utilizes micro-dilution method for antimicrobial susceptibility testing. Meropenem concentration range: 0.004–8 ug/ml. System is designed for 18-24 hour incubation periods. Standard laboratory equipment for clinical microbiology.

Indications for Use

Indicated for clinical susceptibility testing of gram-negative and gram-positive organisms using the Sensititre 18-24 hour MIC or Breakpoint Susceptibility system. Specifically includes testing gram-negative isolates against Meropenem in the dilution range of 0.004–8 ug/ml.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 30 1998

Cynthia C. Knapp Director Lab Services AccuMed International, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145

Re: K983244

Trade Name: Sensititre 18-24 Hour Susceptibility Plates with addition Meropenem Regulatory Class: II Product Code: JTW Dated: September 2, 1998 Received: September 16, 1998

## Dear Ms. Knapp:

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 (QS) 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 (if known):

Device Name: Susceptibility Test Panel

Indications For Use:

The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.

This 510(k) is for the addition of Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wordy Dubois

510(k) Number

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-The-Counter Use

(Optional Format 1-2-96)