(88 days)
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml for testing fastidious Haemophilus influenzae on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptoccus pneumoniae MIC or Breakpoint Susceptibility System.
Imipenem-relebactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Haemophilus influenzae
Not Found
The provided text describes a 510(k) premarket notification for a medical device called the "Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam". This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically focusing on Imipenem-relebactam for Haemophilus influenzae.
However, the provided document is a regulatory approval letter and indications for use statement. It does not contain any information regarding the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your specific questions about the device's performance and the study that proves it meets acceptance criteria.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed test report.
Therefore, I cannot provide the requested table or information regarding the study.
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June 30, 2023
Thermo Fisher Scientific Cynthia Knapp Director R&D, AST and Pharma One Thermo Fisher Way Oakwood Village, Ohio 44146
Re: K230935
Trade/Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: March 31, 2023 Received: April 3, 2023
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230935
Device Name
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml .
Indications for Use (Describe)
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml for testing fastidious Haemophilus influenzae on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptoccus pneumoniae MIC or Breakpoint Susceptibility System.
Imipenem-relebactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Haemophilus influenzae
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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).