SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062783 · Trek Diagnostic Systems, Inc. · JWY · Oct 26, 2006 · Microbiology

Device Facts

• Record ID: K062783
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Oct 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species.

Device Story

Sensititre® HP MIC Susceptibility plates are multi-well plastic microtitre plates containing dried, stabilized antimicrobics for broth dilution susceptibility testing. The device accepts clinical isolates of Streptococcus spp. prepared in Mueller-Hinton broth with 2–5% lysed horse blood. The system detects bacterial growth via fluorescence; specific surface enzymes produced by the organism cleave a fluorogenic substrate, releasing a fluorophore. The device is used in clinical laboratories; readings are performed manually or via automated instrumentation (Sensititre® AutoReader or ARIS®). The resulting MIC (minimum inhibitory concentration) informs clinicians of the lowest antimicrobial concentration inhibiting bacterial growth, aiding in the selection of appropriate antibiotic therapy.

Clinical Evidence

No clinical trials were performed. Evidence consists of in vitro bench testing comparing the Sensititre® MIC results to a reference method. Performance was evaluated by testing clinical isolates of Streptococcus species against Gemifloxacin, Linezolid, and Levofloxacin. Results demonstrated essential agreement and categorical agreement between the Sensititre® system and the reference method, supporting the addition of these organisms to the device's indications.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Sensing principle: fluorescence detection of bacterial growth via enzymatic cleavage of fluorogenic substrates. Energy source: automated reader instrumentation. Connectivity: standalone or integrated with Sensititre® AutoReader/ARIS®. Software: automated growth detection algorithm.

Indications for Use

Indicated for clinical susceptibility testing of Streptococcus species (spp.) to gemifloxacin (0.03 – 0.5 ug/mL), linezolid (0.5 – 4 ug/mL), and levofloxacin (0.5 – 16 ug/mL) using Sensititre® HP MIC Susceptibility Plates. For 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.

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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 26 2006

Re: k062783 Trade/Device Name: Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Gemifloxacin (0.03-0.5 ug/ml), Linezolid (1 - 8 ug/ml), Levefloxacin (0.5 - 16 ug/ml), Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: JWY, LRG Dated: September 14, 2006 Received: September 18, 2006

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 requirernents, 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 guestions 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,

Sally antonm

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): 62793

Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Gemifloxacin (0.03-0.5ug/ml), Linezolid (1-8 ug/ml), Levofloxacin (0.5-16 ug/ml)

## Indications For Use: The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species.

This 510(k) is for the addition of Streptococcus spps. to Gemifloxacin (0.03 -0.5 ug/mL), Linezolid (0.5-4 ug/mL), Levolloxacin (0.5-16 ug/mL) for use with the Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

The approved primary "indications for use" and clinical significance of Gemilloxacin is for: Streptococcus pneumoniae

The following in vitro data are available but their clinical significance is unknown: Streptococcus pyogenes

The approved primary "indications for use" and clinical significance of Linezolid is for Streptococcus pneumoniae, (including multi-drug resistant strains) Streptococcus agalactiae Streptococcus pvogenes

The following in vitro data are available but their clinical significance is unknown: Viridans group streptococci

The approved primary "indications for use" and clinical significance of Levofloxacin is for: Streptococcus pneumoniae (including multi-drug resistant strains) Streptococcus pyogenes

The following in vitro data are available but their clinical significance is unknown:

Viridans group streptococci Streptococcus agalactiae Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus milleri

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) | | | | | | |
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Freddie M. Focke
Division Sign-Off

;vice

Evaluation and Safe

K062783