SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062816 · Trek Diagnostic Systems, Inc. · JWY · Nov 1, 2006 · Microbiology

Device Facts

• Record ID: K062816
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Nov 1, 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® MIC Susceptibility plates are multi-well microtitre plates containing dried, stabilized antimicrobics; used for quantitative antimicrobial susceptibility testing (AST). Inoculum prepared from colonies via direct method; added to Mueller-Hinton broth with 2–5% lysed horse blood. Plates incubated 20–24 hours in non-CO2 incubator. Growth detected via fluorescence; bacterial surface enzymes cleave fluorogenic substrate, releasing fluorophore. Fluorescence intensity correlates with bacterial growth. MIC determined by lowest antimicrobial concentration inhibiting growth. Readings performed manually or via Sensititre® AutoReader/ARIS® instrumentation. Results assist clinicians in selecting appropriate antibiotic therapy for Streptococcus infections.

Clinical Evidence

No clinical trial data provided. Performance is based on in vitro susceptibility testing data comparing the Sensititre® HP MIC plate results to standard reference methods for the specified Streptococcus species and antimicrobial agents.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Fluorescence-based growth detection via enzymatic cleavage of fluorogenic substrate. Energy source: automated reader instrumentation. Dimensions: microtitre plate format. Connectivity: compatible with Sensititre® AutoReader/ARIS®. Software: automated reading algorithm. Sterilization: not specified.

Indications for Use

Indicated for in vitro clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species (including S. agalactiae, S. pyogenes, and Viridans group streptococci) against Meropenem, Moxifloxacin, and Penicillin. 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 & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

NOV - 1 2006

Re: k062816 Trade/Device Name: Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Meropenem (0.25-2 ug/ml). Moxifloxacin (0.25 - 8 µg/ml), Penicillin (0.03 - 8 µg/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 15, 2006 Received: September 20, 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 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) I his icher will anow you to ough mating of substantial equivalence of your device to a legally premarket notification: "The PDIs 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, If you desire specific introllion and advertising of your device, please contact the Office of In of questions on the prometic Device Evaluation and Safety at [phone]. Also, please note the vitro Daglesue Deliver by reference to premarket notification" (21CFR Part 807.97). It guilation entition on your responsibilities under the Act may be obtained from the Other general mionmation on Jour respectional 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, autry

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): \$(0) 2816

Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Meropenem (0.25-2ug/ml), Moxifloxacin (0.25-8 µg/ml), Penicillin (0.03-8 µg/ml)

Indications For Use:

The Sensitire® 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 Meropenem (0.25 -2 ug/mL), Moxifloxacin (0.25-8 ug/mL), Penicillin (0.03-8 ug/mL) for use with the Sensititle® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .

The approved primary "indications for use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Viridans group streptococci The approved primary "indications for use" and clinical significance of Moxifloxacin is for Streptococcus pneumoniae, (including penicillin-resistant strains) Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown; Streptococcus agalactiae Viridans group streptococci The approved primary "indications for use" and clinical significance of Penicillin is for: Streptococcus pneumoniae

Streptococcus pyogenes

Viridans group streptococci

Streptococcus agalactiae

Streptococcus (beta-hemolytic group )

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)

CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie L. Poole
Division Sign-Off

n Viro Diagnostic Devic 1628 033 0 8 6 2222

510(k) K062816