(224 days)
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Cefiderocol Disc (30μg) FDC30 can be used to determine susceptibility to Cefiderocol against the following bacteria for which Cefiderocol has been shown to be active both clinically and in vitro:
For Complicated Urinary Tract Infections (cUTI): Gram-negative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruqinosa
For Hospital Acquired Bacterial Pneumonia and ventilator-associated bacterial pneumonia (HABPN VABP):
- Gram-neqative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens
Not Found
The provided text is a 510(k) premarket notification determination letter for the Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30. It outlines the FDA's decision that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document specifies the regulatory classification and indications for use of the device, but it does not contain the detailed acceptance criteria and study results typically found in a clinical study report or a summary of safety and effectiveness data (SSED).
Therefore, I cannot provide the information requested in your prompt based solely on the provided text. The prompt asks for specifics like:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC study results.
- Standalone performance.
- Type of ground truth used.
- Training set sample size and ground truth establishment.
This type of information is usually found in the submission itself (which this letter refers to as having been reviewed) or in a separate clinical study report, not in the FDA's determination letter.
To answer your request, I would need access to the actual study data, which is not present in this regulatory letter.
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July 30, 2021
Oxoid Limited (Part of Thermo Fisher Scientific) Amie Lovatt Scientist II (510(k) Specialist) Wade Road Basingstroke, Hampshire RG24 8PW United Kingdom
Re: K203700
Trade/Device Name: Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: December 17, 2020 Received: December 18, 2020
Dear Amie Lovatt:
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.
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
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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 medical devices and radiation-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, 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)
Device Name
Thermo Scientific Oxoid Cefiderocol Disc (30μα) FDC30
Indications for Use (Describe)
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Cefiderocol Disc (30μg) FDC30 can be used to determine susceptibility to Cefiderocol against the following bacteria for which Cefiderocol has been shown to be active both clinically and in vitro:
For Complicated Urinary Tract Infections (cUTI): Gram-negative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruqinosa
For Hospital Acquired Bacterial Pneumonia and ventilator-associated bacterial pneumonia (HABPN VABP):
- Gram-neqative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
| x | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).