SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL

K041534 · Trek Diagnostic Systems, Ltd. · JWY · Jul 27, 2004 · Microbiology

Device Facts

• Record ID: K041534
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL
• Applicant: Trek Diagnostic Systems, Ltd.
• Product Code: JWY · Microbiology
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae. The Sensititre® 18-24 hour MIC Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of Gram negative and Gram positive organisms.

Device Story

Sensititre® MIC Susceptibility plates are multi-well plastic microtitre plates containing dried, stabilized antimicrobics; microversion of broth dilution method. Inoculum prepared in Mueller-Hinton broth (with 2-5% lysed horse blood for S. pneumoniae), Haemophilus test medium (for H. influenzae), or Mueller-Hinton broth (for S. aureus). Plates sealed, incubated 20-24 hours at 34-36°C. Growth detected via fluorescence (automated) or turbidity/cell deposit (manual). Automated reading performed on Sensititre® AutoReader® or ARIS®; manual reading via viewer or SensiTouch®. Output is quantitative MIC value. Used in clinical labs to determine antibiotic susceptibility; results guide antimicrobial therapy decisions for patients with bacterial infections.

Clinical Evidence

Bench testing only. Reproducibility testing performed on 75 isolates (25 H. influenzae, 25 S. pneumoniae, 25 gram-positive) across three sites, demonstrating >95% reproducibility. Method comparison against NCCLS broth reference panels using clinical and challenge isolates showed high essential agreement (EA) and category agreement (CA). For manual reading, EA was 98.7-100% and CA was 98.9-100%. For automated reading, EA was 94.4-98.6% and CA was 100%.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Fluorescence-based growth detection (automated) or turbidity/visual (manual). Dimensions: microtitre plate format. Connectivity: standalone or integrated with AutoReader®/ARIS® systems. Software: automated reading algorithm. Sterilization: not specified.

Indications for Use

Indicated for susceptibility testing of Haemophilus influenzae and Streptococcus pneumoniae using the Sensititre® HP MIC plate, and Staphylococcus aureus and other gram positive isolates using the Sensititre® 18-24 hour MIC Susceptibility panel, with Telithromycin (0.002-16 µg/ml). 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 Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 2 7 2004

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

k041534 Re:

Trade/Device Name: Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC/Susceptibility Plate and Test Panel for Telithromycin 0.002-16μg/ml

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: June 8, 2004 Received: June 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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## Page 2

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 yours,

Salazar

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

Ko41534 510(k) Number (if known):

Device Name: Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC/ Susceptibility Plate and Susceptibility Test Panel for: Telithromycin 0.002-16ug/ml

Indications For Use:

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

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 Telithromycin in the dilution range of 0.002-16µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcusion pneumoniae and the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance for Telithromycin is for: Streptococcus_pneumoniae (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, and Staphylococcus aureus (methicillin and erythromycin susceptible isolates only). In vitro data, without clinical correlation is provided for: Streptococcus pyogenes(erythromycin susceptible isolates only).

Prescription Use × (Part 21 CFR 801 Subpart D)

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)

Freddie W. Poole

Division Sign-Off

Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

VAL 1534