SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES

K083606 · Trek Diagnostic Systems, Inc. · JWY · Mar 24, 2009 · Microbiology

Device Facts

• Record ID: K083606
• Device Name: SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Mar 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® 18 – 24 hour MIC or Breakpoint Susceptibility System is an in-vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative and Gram positive organisms.

Device Story

Sensititre Susceptibility System is a micro-broth dilution method for antimicrobial susceptibility testing (AST). Device uses dried microtiter plates pre-dosed with Doxycycline (0.03–16μg/mL). Pure culture isolates are suspended in broth (0.5 McFarland standard), inoculated into plates using Sensititre AutoInoculator, and incubated for 18–24 hours. Growth is detected via fluorescence monitoring of bacterial surface enzyme activity; fluorogenic substrates release a fluorophore upon cleavage. Results are read manually (viewer/SensiTouch) or automatically (AutoReader/ARIS). System provides Minimum Inhibitory Concentration (MIC) and SIR interpretation. Healthcare providers use results to guide antimicrobial therapy decisions for bacterial infections.

Clinical Evidence

Performance evaluated via method comparison against CLSI broth dilution reference. Study included 935 Gram-negative and Gram-positive isolates (800 fresh clinical, 135 stock challenge). Combined EA and CA were >90% for both manual and automated reading methods. No very major (vmj) or major (maj) errors observed. Reproducibility testing across three sites showed >95% reproducibility. Quality control performed daily using S. aureus, E. faecalis, and E. coli strains.

Technological Characteristics

Microtiter plate-based susceptibility testing system. Uses dehydrated antimicrobial agents (Doxycycline) in specific concentration ranges. Principle of operation is broth microdilution. System is designed for automated or manual inoculation and incubation. No specific software algorithm or complex electronic sensing described; relies on visual or automated growth detection in wells.

Indications for Use

Indicated for clinical susceptibility testing of non-fastidious Gram negative and Gram positive organisms, specifically: Escherichia coli, Klebsiella species, Enterobacter aerogenes, Acinetobacter species, Streptococcus pyogenes, Enterococcus species (faecalis and faecium), and Staphylococcus aureus. Doxycycline is not the drug of choice for staphylococcal infections. 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.

Predicate Devices

• Sensititre 18-24 hour MIC or Breakpoint Susceptibility System (K083601)

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 U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 2 4 2009

Ms. Cynthia C. Knapp Director Lab Services Trek Diagnostic Systems Inc 982 Keynote Circle Suite 6 Cleveland, OH 44131

Re: k083606

> Trade/Device Name: Sensitite® 18-24 hour MIC or Breakpoint Susceptibility System Doxycycline (0.03 -16 µg/mL) - Gram Negative and Gram Positive Regulation Number: 21 CFR 866.1640

Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: March 16, 2009 Received: March 17, 2009

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. Ilsting 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Sally attayma

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): t(083606

Device Name: The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" with Doxycycline (0.03 - 16μg/ml) for Gram Negative and Gram Positive's

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 and gram negative organisms.

This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for:

Aerobic and facultative Gram-negative and Gram-positive microorganisms:

Escherichia coli Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcus aureus*

*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Prescription Use X (Part 21 CFR 801 Subpart D)

1. September 2004. IS . Chican and the

AND/OR

Over-The-Counter Use (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)

Fredda L. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K083601