SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

K040619 · Trek Diagnostic Systems, Inc. · JWY · Apr 7, 2004 · Microbiology

Device Facts

• Record ID: K040619
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC plates are in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and other fastidious organisms. This will include clindamycin in the dilution range of 0.016 - 8 ug/mL to the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC susceptibility plate for testing Streptococcus pneumoniae isolates. Not routinely reported on isolates from the urinary tract Prescription use only

Device Story

Sensititre® HP MIC plates are multi-well plastic microtitre plates containing dried, stabilized antimicrobics; used for quantitative antimicrobial susceptibility testing (AST). Inoculum prepared in 2–5% lysed horse blood; plates sealed and incubated at 34–36°C for 20–24 hours. Device detects bacterial growth to determine Minimum Inhibitory Concentration (MIC). Automated reading performed via Sensititre® AutoReader® or ARIS® using fluorescence technology; manual reading performed via viewer or SensiTouch® based on turbidity. Fluorescence detection involves generating a fluorescent product from a non-fluorescent substrate conjugated to enzyme substrates; fluorescence intensity correlates with bacterial growth. Results provide MIC and categorical interpretation (SIR) to guide antimicrobial therapy for fastidious organisms. Used in clinical microbiology laboratories.

Clinical Evidence

Bench testing only. The submission relies on performance validation of the Sensititre MIC plate for the specific antibiotic-organism combination (Clindamycin/Streptococcus pneumoniae) compared to reference broth microdilution methods. No clinical trial data provided.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Fluorescence-based growth detection (automated) or turbidity-based (manual). Inoculum standardized via nephelometer. Connectivity via Sensititre® AutoReader® or ARIS®. Software-assisted reading of MIC values.

Indications for Use

Indicated for in vitro clinical susceptibility testing of Haemophilus and Streptococcus pneumoniae isolates to Clindamycin (0.016-8μg/ml).

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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 7 2004

Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145

Re: k040619

> Trade/Device Name: Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate for Clindamycin 0.016-8ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 9, 2004 Received: March 9, 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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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,

SaaAtzS

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): K 040619

Device Name: Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate, Clindamycin 0.016-8ug/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.

This 510(k) is for the addition of Clindamycin in the dilution range of 0.016-8μg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Clindamycin is for: Streptococcus pneumoniae.

Rhiannon Shively for Sally Hoyvat
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040619

Prescription Use X (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)