SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE

K073653 · Trek Diagnostic Systems, Inc. · JWY · Mar 20, 2008 · Microbiology

Device Facts

• Record ID: K073653
• Device Name: SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Mar 20, 2008
• 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 positive isolates comprising of Staphylococci, Enterococci, and beta hemolytic Streptococci other than S. pneumoniae.

Device Story

Sensititre system performs antimicrobial susceptibility testing (AST) via micro-broth dilution. Device uses dried antimicrobial agents in microdilution plates; inoculated with patient bacterial isolates; incubated 18–24 hours. Principle of operation: fluorescence-based detection of bacterial growth; fluorogenic substrate added to broth; bacterial surface enzymes cleave substrate to release fluorophore; fluorescence intensity correlates to growth. Output: qualitative/quantitative susceptibility results (MIC or breakpoint). Used in clinical laboratories; operated by technicians. Results read manually (viewer/SensiTouch) or automatically (AutoReader/ARIS). Output informs clinicians of inducible clindamycin resistance in Staphylococcus spp., guiding antibiotic selection.

Clinical Evidence

Performance evaluated using 207 S. aureus and 200 coagulase-negative Staphylococcus isolates across three sites. Compared against CLSI broth dilution reference method. Manual read method showed 100% category agreement (CA) for both groups. Automated read method showed 100% CA for S. aureus and 98.9% CA for coagulase-negative Staphylococcus (2 very major errors). Reproducibility testing performed on 15 isolates with acceptable results. QC performed daily using S. aureus ATCC BAA-976 and BAA-977.

Technological Characteristics

Micro-broth dilution AST system. Fluorescence-based growth detection via fluorogenic substrate cleavage by bacterial surface enzymes. Dried antimicrobial agents in microdilution plates. Incubation 34-36°C for 18-24 hours. Connectivity via Sensititre AutoReader or ARIS instrumentation. Manual reading options include viewer or SensiTouch.

Indications for Use

Indicated for clinical susceptibility testing of gram-positive and gram-negative organisms. Specifically, the Dtest is indicated for Staphylococcus spp. isolates that are erythromycin-resistant (MIC ≥ 8µg/ml) and clindamycin-susceptible or intermediate (MIC < 2µg/ml) to detect inducible clindamycin resistance.

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 2098 Gaither Road Rockville MD 20850

# MAR 2 0 2008

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

Re: k073653

Trade/Device Name: The Sensititre® 18-24 MIC or BP Susceptibility System with Dtest l and 2 (1 contains erythromycin at 4μg/ml and clindamycin at 0.5ug/ml and 2 contains erythromycin at 8ug/ml and clindamycin 1.5ug/ml ) broth test for Staphylococcus spp.

Regulation Number: 21 CFR 866.1640

Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LRG Dated: March 13, 2008 Received: March 14, 2008

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 misbuanding 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 not 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 attaym

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): k073653

#### Device Name:

The "Sensititre® 18-24 hour MIC or BP Susceptibility Test System" with Dtest 1 and 2 (1 contains erythromycin at 4ug/ml and clindamycin at 0.5ug/ml and 2 contains erythromycin at 8ug/ml and clindamycin at 1.5ug/ml) broth test for Staphylococcus spp.

### 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 the addition of: "Dtest"

The Dtest for Broth Microdilution Test is for Staphylococcus spp. resistant to (MIC's ≥ 8ug/ml) erythromycin and susceptible or intermediate (MIC's < 2ug/ml) to clindamycin. With these isolates a Dtest 1 (4/0.5 ug/ml) or 2 (8/1.5 ug/ml) or both 1 and 2 are positive (growth) the test should be reported as inducible clindamycin resistance. If with these isolates there is no growth in both Dtest 1 and 2 the isolates should be reported as negative for inducible resistance.

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)
Division Sign-Off We Schof

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) k073653