SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K014258 · Trek Diagnostic Systems, Inc. · JWY · Feb 19, 2002 · Microbiology

Device Facts

• Record ID: K014258
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for the susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Cefdinir in the dilution range of 0.016 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical indications of the Sensititre HP MIC plate are for Streptococcus pneumoniae (penicillin-susceptible strains only).

Device Story

Sensititre HP MIC Susceptibility Plates are in vitro diagnostic devices used in clinical laboratories to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against specific bacteria. This specific submission adds the antibiotic Cefdinir (0.016–4 µg/ml) to the existing panel. The device consists of microtiter plates containing dehydrated antimicrobial agents. Clinical laboratory technicians inoculate the plates with patient bacterial isolates; the plates are incubated; bacterial growth is observed to determine the MIC. Results assist physicians in selecting appropriate antibiotic therapy for patients with infections caused by Streptococcus pneumoniae or Haemophilus influenzae. The device provides quantitative susceptibility data to guide clinical decision-making and improve patient outcomes through targeted antimicrobial treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing demonstrating the performance of the Sensititre HP MIC plate with the addition of Cefdinir compared to standard reference methods for antimicrobial susceptibility testing.

Technological Characteristics

Microtiter plate format containing dehydrated antimicrobial agents. Principle of operation is broth microdilution for MIC determination. Intended for in vitro diagnostic use in clinical laboratory settings.

Indications for Use

Indicated for in vitro susceptibility testing of Streptococcus pneumoniae (penicillin-susceptible strains only) and Haemophilus influenzae isolates using Cefdinir.

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.

Predicate Devices

• Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates (K014236)

Submission Summary (Full Text)

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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 human figure with three arms or lines extending upwards, representing health and well-being. The figure is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 9 2002

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

k014258 Re:

K014236
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY Dated: December 21, 2001 Received: December 26, 2001

Dear Ms. Knapp:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon o re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars) the enactment date of the Medical Device Amendments, or to connine.co. prior to May 20, 1773, and once with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that to novice, subject to the general controls provisions of the Act. The r ou may, therefore, mainer of the Act include requirements for annual registration, listing of gencial controls provisions of ractice, 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 If your device is classified (500 a00 voy als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to back additions, Title 21, Parts 800 to 898. 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 I lease be action and I Draination that your device complies with other requirements of the Act that I Dri has made a aswd regulations administered by other Federal agencies. You must of any I cuchares and regarations and regarations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) of X Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lower will and hy you ding of substantial equivalence of your device to a legally marketed nouticate 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]) e rates of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on Judi 100 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If known):

Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

Indications For Use:

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in The Sellsmite Hacmopiliaal susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the addition of Cefdinir in the dilution range of 0.016 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus Sellstitle Tracmophilus influenzae isolates. The "Indications for Use" and clinical pheumoniae and Tractional inistrations of the moniae (penicillin-susceptible strains only)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <p>(Division S</p> <p>Division of Clinical Laboratory Devices</p> |
|---------------|-------------------------------------------------------------------|
| 510(k) Number | K 014258 |

| Prescription Use<br>(Per 21 CFR 801.109 | OR | Over-The-Counter Use |
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