MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062839 · Trek Diagnostic Systems, Inc. · JWY · Nov 9, 2006 · Microbiology

Device Facts

• Record ID: K062839
• Device Name: MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Nov 9, 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. This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

Device Story

Sensititre® MIC Susceptibility plates are multi-well microtitre plates containing dried, stabilized antimicrobics; used for quantitative antimicrobial susceptibility testing (AST). Input: clinical isolates of Streptococcus spp. inoculated into Mueller-Hinton broth with 2–5% lysed horse blood. Principle: fluorescence-based detection of bacterial growth; bacterial surface enzymes cleave a fluorogenic substrate, releasing a fluorophore; fluorescence intensity correlates with bacterial growth. Operation: plates incubated 20–24 hours; read manually or via Sensititre® AutoReader/ARIS®. Output: MIC values (lowest antimicrobial concentration inhibiting growth). Used in clinical laboratories to determine susceptibility profiles, guiding antibiotic treatment decisions for patients with bacterial infections.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the Sensititre® MIC results for the specified antibiotics against Streptococcus species to a reference method. Data demonstrated acceptable categorical agreement and essential agreement between the subject device and the reference standard.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Sensing principle: fluorescence detection of bacterial growth via enzymatic cleavage of fluorogenic substrates. Energy source: automated reader instrumentation. Dimensions: standard microtitre plate format. Connectivity: compatible with Sensititre® AutoReader or ARIS® for automated data capture. Sterilization: not specified.

Indications for Use

Indicated for clinical susceptibility testing of Streptococcus species (spp.) to tetracycline, trimethoprim/sulphamethoxazole, and vancomycin using Sensititre® HP MIC Susceptibility Plates.

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

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV - 9 2006

k062839 Re:

> Trade/Device Name: Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, for Tetracycline (0.5-8 ug/ml), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 µg/ml), Vancomycin (0.5-4 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: September 19, 2006 Received: September 27, 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 cither 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). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, anton

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):

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Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Tetracycline (0.5-8μg/ml), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 μg/ml), Vancomycin (0.5-4 με/ml)

#### Indications For 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.

This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

#### Tetracycline is for:

Streptococcus pneumoniae Streptococcus agalactiae Streptococcus pyogenes Viridans group streptococci Streptococcus (beta-hemolytic group ) Trimethoprim/Sulphamethoxazole is for

Streptococcus pneumoniae

### Vancomycin 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)

Concurrence of CDRH, Office of In Vitro Diagnostiq I

stic Devices (OIVD)
Freedda M. Poole
Division Sign-Off

Thagnostic Device

K062839