(29 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae. This 510(k) is for the addition of Clindamycin in the dilution range of 0.016-8μg/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 Clindamycin is for: Streptococcus pneumoniae.
Not Found
This document is a 510(k) clearance letter for an in vitro diagnostic product, specifically a susceptibility plate for Clindamycin. It does not contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, or performance metrics.
The provided text focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices. It identifies the device, its intended use, and the regulatory classification. However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test or training sets, or data provenance.
- Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
- Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
- The type of ground truth used.
Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and study details.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 7 2004
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K040619
Trade/Device Name: Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate for Clindamycin 0.016-8ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 9, 2004 Received: March 9, 2004
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 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 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 (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,
SaaAtzS
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): K 040619
Device Name: Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate, Clindamycin 0.016-8ug/ml
Indications For Use:
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae.
This 510(k) is for the addition of Clindamycin in the dilution range of 0.016-8μg/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 Clindamycin is for: Streptococcus pneumoniae.
Rhiannon Shively for Sally Hoyvat
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040619
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)
§ 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).