SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K033522 · Trek Diagnostic Systems, Inc. · JWY · Feb 3, 2004 · Microbiology

Device Facts

• Record ID: K033522
• Device Name: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Feb 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® MIC Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This will include daptomycin in the dilution range of 0.03-64 ug/mL to the gram positive Sensititre® MIC Susceptibility panel for testing Staphylococcus spp, Enterococcus spp., and Streptococcus spp.

Device Story

Sensititre® MIC Susceptibility system performs in vitro antimicrobial susceptibility testing (AST) for gram-positive organisms. System uses multi-well plastic microtitre plates pre-dosed with dried, stabilized daptomycin. Inoculum prepared from colonies via direct inoculation method (0.5 McFarland). Principle of operation: fluorescence-based growth detection; non-fluorescent substrate added to inoculum; bacterial growth generates fluorescent product; fluorescence intensity correlates with bacterial activity. Minimum Inhibitory Concentration (MIC) determined by lowest antimicrobial dilution inhibiting growth. Automated readings performed via Sensititre® AutoReader® or ARIS®; manual reading also supported. Used in clinical microbiology laboratories. Provides quantitative susceptibility results to guide antibiotic therapy decisions. Benefits include standardized, automated AST workflow for daptomycin.

Clinical Evidence

No clinical data provided. The submission relies on in vitro performance data comparing the Sensititre system's MIC results for Daptomycin against a reference method to demonstrate analytical performance.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Fluorescence-based growth detection; non-fluorescent substrate conversion. Automated reading via Sensititre® AutoReader® or ARIS®. Incubation 18-24 hours. Standardized inoculum (0.5 McFarland). Complies with NCCLS M7 (M100-S13) standards.

Indications for Use

Indicated for clinical susceptibility testing of gram-positive organisms, specifically S. aureus (including MRSA), E. faecalis (vancomycin-susceptible), S. agalactiae, and S. pyogenes. Provides in vitro data for S. epidermidis (including MRSA), E. faecalis (vancomycin-resistant), E. faecium (including vancomycin-resistant), and S. haemolyticus.

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with outstretched wings, represented by three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 3 2004

Ms. Cindy Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 982 Keynote Circle - Suite 6 Cleveland, OH 44131

Re: k033522

> Trade/Device Name: Susceptibility Test Panel for Daptomycin 0.03-64 us/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY; LRG Dated: January 5, 2004 Received: January 8, 2004

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 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).

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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). 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/dsma/dsmamain.html.

Sincerely vours.

Saqartys

Sally A. Hojvat, M.Sc., Ph.D. 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

510(k) Number (if known): K033522

Device Name: Susceptibility Test Panel for Daptomycin 0.03-64μg/ml

Indications For Use:

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms.

This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 -64 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcus faecalis (vancomycin-susceptible strains only), Streptococcus agalactiae and Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.

× 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)

Naas at 2/3/04
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO33522 510(k)_