ETEST TETRACYCLINE by AB BIODISK

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 application is for MIC determination of Tetracycline in the range of 0.016 - 256 µg/ml with Streptococcus spp.

Previously cleared applications include non-fastidious Gram positive and Gram negative aerobic bacteria, H. influenzae and S. pneumoniae.

Device Description

Not Found

AI/ML Overview

While the provided text describes the regulatory approval of the Etest® Tetracycline for determining antimicrobial susceptibility, it does not contain the detailed clinical study information and acceptance criteria typically found in a clinical trial report or a comprehensive technical document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding specific study parameters like sample size, data provenance, expert involvement, or ground truth details.

However, based on the context of the 510(k) submission, I can infer some general information about the type of study that would have been conducted and the nature of the acceptance criteria.

Inferred Information based on 510(k) Approval for an In Vitro Diagnostic Device:

For a device like the Etest® Tetracycline, which determines Minimum Inhibitory Concentration (MIC), the acceptance criteria and study would typically involve:

Comparison to a "Gold Standard" Reference Method: The primary study would compare the Etest's MIC results against an established, validated reference method (e.g., broth microdilution or agar dilution as defined by CLSI/NCCLS standards at the time).
Accuracy Metrics: Acceptance criteria would likely involve:
- Essential Agreement (EA): The percentage of MIC values that are within ±1 (or sometimes ±2) doubling dilutions of the reference method.
- Categorical Agreement (CA): The percentage of isolates where the Etest and the reference method agree on the susceptibility categorization (e.g., Susceptible, Intermediate, Resistant) based on established breakpoints.
- Major Discrepancies (MD): Instances where the Etest indicates susceptible and the reference indicates resistant.
- Very Major Discrepancies (VMD): Instances where the Etest indicates resistant and the reference indicates susceptible.
Reproducibility/Precision: Studies demonstrating consistent results when the test is performed multiple times on the same isolate under similar conditions (within-laboratory and between-laboratory).

Specific Information NOT Present in the Provided Text:

All of the following information is not available in the provided document:

Table of Acceptance Criteria and Reported Device Performance: This document is a regulatory approval letter, not a study report. It states that the device is "substantially equivalent," implying that a study was done and met criteria, but it does not detail those criteria or the performance metrics.
Sample size used for the test set and the data provenance: No numerical data on sample size, country of origin, or retrospective/prospective nature of the study is given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. For microbiology, the "ground truth" would typically be derived from the reference method, not human expert interpretation of the test itself.
Adjudication method: Not applicable as the "ground truth" is typically the reference method's result.
Multi-reader multi-case (MRMC) comparative effectiveness study: This is not relevant for an in vitro diagnostic device like Etest, which provides a quantitative result (MIC). MRMC studies are typically for imaging or interpretive diagnostics where human readers analyze data.
Standalone performance (algorithm only): The Etest is a physical strip. Its "performance" is inherently based on the chemical reaction and visual interpretation of the ellipse formation. There isn't an "algorithm only" performance in the traditional sense of AI.
Type of ground truth used: While not explicitly stated, for an antimicrobial susceptibility test, the ground truth would be the results obtained from a recognized reference method (e.g., CLSI/NCCLS standard broth microdilution or agar dilution).
Sample size for the training set: Not applicable; the Etest is not an AI/ML device that requires a "training set" in the computational sense.
How the ground truth for the training set was established: Not applicable.

Summary of what the document DOES tell us:

Device Name: Etest® Tetracycline
Indications For Use: Quantitative determination of Tetracycline MIC (0.016 - 256 µg/ml) for Streptococcus spp. It also mentions previous clearance for other bacteria.
Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
Device Type: In vitro diagnostic device.

To obtain the detailed study information, one would typically need to consult the original 510(k) submission document (if publicly available in full detail), the device's labeling (package insert), or peer-reviewed publications validating the Etest device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 7 1998

Anne Bolmström President Ab Biodisk Dalvägen 10, S-169 56 Solna Sweden

Re: K980347 Trade Name: Etest® Tetracycline Regulatory Class: II Product Code: JWY Dated: May 6, 1998 Received: May 8, 1998

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Autman

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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Enclosure 4

Page 1 of 1

510(k) Number (if known): K980347

Device Name: Etest® Tetracycline

Indications For Use:

For in vitro diagnostic use:

This application is for MIC determination of Tetracycline in the range of 0.016 - 256 µg/ml with Streptococcus spp.

Previously cleared applications include non-fastidious Gram positive and Gram negative aerobic bacteria, H. influenzae and S. pneumoniae.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED)

Concurrence of C DRH, Office of Device Evaluation (ODE)

Division of Clinical Laboratory Devices 210(k) Number K98034

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).