(89 days)
The Sensititre 20 - 24-hour Haemophilus influenzae Streptococcus pneumoniae MIC or Break is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp., (including S. pneumoniae) and delafloxacin in the dilution range of 0.000125 - 8 ug/mL for testing H. influenzae on the Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Delafloxacin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp. For Community Acquired Bacterial Pneumonia (CABP) Streptococcus pneumoniae Haemophilus influenzae
Not Found
The provide FDA 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.
The document is a clearance letter for a medical device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin), indicating it has been deemed substantially equivalent to a predicate device. While it mentions the device's intended use and the specific drug for susceptibility testing, it does not include the specifics of the performance study.
Typically, such information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details) would be explicitly laid out in the 510(k) summary submitted by the manufacturer to the FDA. The provided text is the FDA's response to that submission and does not detail the underlying studies.
Therefore, I cannot provide the answer in the requested format based on the given input.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2023
ThermoFisher Scientific Cynthia Knapp Director R&D, AST and Pharma One Thermo Fisher Way Oakwood Village, Ohio 44146
Re: K223844
Trade/Device Name: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/mL (Streptococcus pneumoniae) and 0.000125-8ug/mL (Haemophilus influenzae)
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: December 20, 2022 Received: December 22, 2022
Dear Cynthia 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found 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.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
K223844
Device Name
Sensititre 20 -24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint System with Delafloxacin in the dilution range of 0.00025-8ugml (Streptococcus pneumoniae) and 0.000125-8ug/ml (Haemophilus influenzae)
Indications for Use (Describe)
The Sensititre 20 - 24-hour Haemophilus influenzae Streptococcus pneumoniae MIC or Break is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp., (including S. pneumoniae) and delafloxacin in the dilution range of 0.000125 - 8 ug/mL for testing H. influenzae on the Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.
Delafloxacin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
For Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp.
For Community Acquired Bacterial Pneumonia (CABP)
Streptococcus pneumoniae Haemophilus influenzae
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).