SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES by TREK DIAGNOSTIC SYSTEMS, INC.

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of H. influenzae/S. pneumoniae.

This 510(k) is for the addition of Ertapenem in the dilution range of 0.008-16ug/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 Ertapenem is for: Streptococcus pneumoniae ( penicillin susceptible strains only) and Haemophilus influenzae (Beta-lactamase negative strains only). In vitro data. without clinical correlation is provided for: Streptococcus pneumoniae (penicillinintermediate strains only) and Haemophilus influenzae (Beta-lactamase positive strains)

Device Description

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AI/ML Overview

This document contains information related to the 510(k) premarket notification for the "Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate For Ertapenem 0.008-16ug/ml". The provided text primarily focuses on the regulatory approval and indications for use, but it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance data.

Specifically, the document lacks:

A table of acceptance criteria and reported device performance.
Sample sizes used for test and training sets.
Data provenance (country, retrospective/prospective).
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study details.
Standalone algorithm performance.
Type of ground truth used (pathology, outcomes, etc.).
How ground truth for the training set was established.

The provided text only states that the device is an "in vitro diagnostic product for clinical susceptibility testing" and for the "addition of Ertapenem." It also mentions "In vitro data without clinical correlation is provided" for certain strains, which implies that some in vitro testing was done but the full details are not present in this excerpt.

To provide a complete answer with all the requested information, you would need to consult the full premarket notification submission (K040846) which would include the detailed study protocols, results, and acceptance criteria.

Summary

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Indications for Use

510(k) Number (if known): K040846

Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate For Ertapenem 0.008-16ug/ml

Indications For Use:

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of H. influenzae/S. pneumoniae.

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)

Fiedder M. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

11 14 1846

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 1 2004

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

Re: K040846

Trade/Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate for Ertapenem 0.008-16ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 31, 2004 Received: April 1, 2004

Dear Ms. Knapp:

This letter corrects our substantially equivalent letter of April 26, 2004, regarding the change of address.

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 i 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 compriswith 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 0 ffice of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saartys

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

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
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.(b)
Classification. Class II (performance standards).