SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K062681 · Trek Diagnostic Systems, Ltd. · JWY · Oct 13, 2006 · Microbiology

Device Facts

• Record ID: K062681
• Device Name: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
• Applicant: Trek Diagnostic Systems, Ltd.
• Product Code: JWY · Microbiology
• Decision Date: Oct 13, 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 and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species. This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates . oneumonde (HF) MIC Susceptionity Frates - Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Streptococcus agalactiae " "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae Streptococcus spp.

Device Story

Sensititre® HP MIC Susceptibility plates are multi-well plastic 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: micro-broth dilution method; bacterial growth monitored via fluorescence detection of surface enzyme activity. Fluorogenic substrate cleavage releases fluorophore; fluorescence intensity correlates with bacterial growth. Output: MIC values determined by lowest antimicrobial concentration inhibiting growth. Used in clinical laboratories; results read manually or via Sensititre® AutoReader/ARIS® instrumentation. Provides qualitative and quantitative susceptibility data to guide antibiotic therapy decisions.

Clinical Evidence

Bench testing only. The submission provides in vitro data demonstrating the performance of the Sensititre® HP MIC Susceptibility plates for the specified antibiotic-organism combinations. Clinical significance for certain organisms (e.g., Streptococcus agalactiae for specific antibiotics) is noted as unknown.

Technological Characteristics

Multi-well plastic microtitre plates; dried, stabilized antimicrobics. Sensing principle: fluorescence detection of bacterial surface enzyme activity via fluorogenic substrate cleavage. Dimensions: microtitre plate format. Connectivity: compatible with Sensititre® AutoReader or ARIS® for automated reading. Sterilization: not specified. Software: automated reading algorithms for fluorescence intensity quantification.

Indications for Use

Indicated for in vitro susceptibility testing of Streptococcus species, including Viridans group streptococci, Streptococcus pneumoniae, Streptococcus pyogenes, and Streptococcus agalactiae, to the antibiotics Cefepime, Ceftriaxone, and Chloramphenicol 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three branches intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 1 3 2006

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

Re: k062681

Trade/Device Name: Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Cefepime (0.12-8 ug/ml), Chlomaphenicol (4-16 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobiał Susceptibility Test Powder

Regulatory Class: Class II Product Code: JWY, LRG Dated: September 5, 2006 Received: September 8, 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, Orug 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 (1 vire, 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): KOレ 26 8 )

Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Cefepime (0.12-8μg/ml), Ceftriaxone (0.06-2 μg/ml), Chloramphenicol (4-16 μg/ml)

Indications For Use:

Indications For Use.
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.

This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .

oneumonde (HF) MIC Susceptionity Frates -

Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for

Viridans group streptococci.

Streptococcus pneumoniae,

Streptococcus pyogenes

The following in vitro data are available but their clinical significance is unknown:

Streptococcus agalactiae

" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae

Streptococcus spp.

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 Diagnostic Devices

ic Devices (OIVD)

Office of In Vitro Diagnostic Device
Evaluation and Safety

510062 K062681