(48 days)
For in vitro diagnostic use:
Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This Etest 510(k) application is for MIC determination of Cefuroxime in the range of 0.016 - 256 µg/ml with S. pneumoniae.
Previously cleared applications for Cefuroxime are non-fastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Etest® Cefuroxime." It indicates that the device has been found substantially equivalent to a predicate device for its intended use. The document discusses regulatory aspects, but it does not contain a detailed study report with acceptance criteria and device performance statistics as would typically be found in a clinical trial or validation study summary.
Therefore, many of the requested elements cannot be extracted from this specific document.
Based on the provided text, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this clearance letter. The letter only indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets certain unstated criteria similar to those predicates.
- Reported Device Performance: The document specifies the "Indications For Use" as "MIC determination of Cefuroxime in the range of 0.016 - 256 µg/ml with S. pneumoniae." This range itself is not a performance metric but rather a functional scope. No specific performance metrics like accuracy, sensitivity, or specificity are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This device is for determining Minimum Inhibitory Concentration (MIC) for antimicrobial susceptibility, not for image interpretation by human readers. It's an in-vitro diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The Etest is inherently a standalone device in that it provides a direct MIC reading. However, the document does not detail validation studies, so specific "standalone performance" metrics are not available. The application is for "MIC determination," which is an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not provided, but for MIC determination devices, ground truth would typically be established by a reference method (e.g., broth microdilution or agar dilution as per CLSI standards).
8. The sample size for the training set
- Not provided.
9. How the ground truth for the training set was established
- Not provided.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1999
Anne Bolmström President AB BIODISK Dalvägen 10 S-169 56 Solna Sweden
K990722 Re: Trade Name: Etest® Cefuroxime Regulatory Class: II Product Code: JWY Dated: March 1, 1999 Received: March 5, 1999
Dear Ms. Bolmström:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Etest® for Cefuroxime
Indications For Use:
For in vitro diagnostic use:
Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This Etest 510(k) application is for MIC determination of Cefuroxime in the range of 0.016 - 256 µg/ml with S. pneumoniae.
Previously cleared applications for Cefuroxime are non-fastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Woody Dubois(Division Sign-Off)Division of Clinical Laboratory Devices | |
|---|---|
| 510(k) Number | K990722 |
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The Counter Use _______ |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ------------------------------ |
(Optional Format 1-2-96)
§ 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).