SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE

K013580 · Trek Diagnostic Systems, Inc. · JWY · Dec 12, 2001 · Microbiology

Device Facts

• Record ID: K013580
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Dec 12, 2001
• 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 Clarithromycin in the dilution range of 0.016 - 16 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates.

Device Story

Sensititre HP MIC Susceptibility Plates are in vitro diagnostic tools used in clinical laboratories to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against specific bacteria. This device specifically facilitates testing of Streptococcus pneumoniae and Haemophilus influenzae against Clarithromycin (dilution range 0.016–16 µg/ml). The system utilizes microbroth dilution methodology. Laboratory technicians inoculate the plates with patient bacterial isolates; plates are incubated; growth patterns are observed to determine the MIC. Results assist clinicians in selecting appropriate antibiotic therapy for patients with infections caused by these organisms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing of antimicrobial susceptibility performance.

Technological Characteristics

Microbroth dilution susceptibility test panel. Contains dehydrated antimicrobial agent (Clarithromycin) in specific concentrations. Designed for use with standard laboratory incubation equipment. In vitro diagnostic device.

Indications for Use

Indicated for in vitro susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae isolates to the antimicrobial agent Clarithromycin. 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.

Predicate Devices

• Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates (K013360)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus-like symbol with three abstract human figures connected by flowing lines, representing health and well-being. The symbol 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

DEC 1 2 2001

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

Re: k013580

K013360
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Clarithromycin Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: October 26, 2001 Received: October 29, 2001

Dear Ms. Knapp:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the 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 encreativent of the enactment date of the Medical Device Amendments, or to Conniner to May 20, 1978, are cance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I vou may, morelore, mainer of the Act include requirements for annual registration, listing of general 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 to such additional controls. Existing major regulations affecting your device can may or bund in the Code of Federal Regulations, 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 loase of actived that I termination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 comps while/); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable,,the electronic product radiation control provisions (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 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 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] - 12 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 manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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): Kol 3580

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

Indications For Use:

The Sensititte Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in The Sellshure Tracmopinas Busceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the addition of Clarithromycin in the dilution range of 0.016 - 16 µg/ml to This Sto(K) is for the addraon of Claricon of Clariconiae MIC panel for testing Streptococcus the Sensuite fraemophilus influenzae isolates. The "Indications for Use" and clinical significance of Clarithromycin is for: Streptococcus pneumoniae

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Luddi tu. Pocke

| (Division Sign-Off) | Division of Clinical Laboratory Devices |
|---------------------|-----------------------------------------|
| 510(k) Number | K01 3580 |

| Prescription Use | <div> <img alt="checkbox" src="checkbox.png"/> </div> | OR | Over-The-Counter Use |
|------------------|-------------------------------------------------------|----|----------------------|
|------------------|-------------------------------------------------------|----|----------------------|

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use