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 Etest 510(k) application is for MIC determination of Tetracycline in the range of 0.016 - 256 µg/ml with non-fastidious Gram positive and Gram negative aerobic bacteria, H. influenzae, N. gonorrhoeae and Streptococcus spp.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding the Etest® Tetracycline device, extracting information relevant to acceptance criteria and the supporting study, while noting what information is not present in these specific documents.

It's important to understand that the provided text is an FDA 510(k) clearance letter and an "Indications For Use" statement. These documents do not typically contain detailed study designs, acceptance criteria tables, or comprehensive performance data. They refer to a study that was submitted to the FDA, but the details of that study are not explicitly included here.

Therefore, many of your requested points will be answered as "Not explicitly stated in the provided text."

Acceptance Criteria and Device Performance Study Information for Etest® Tetracycline

Given the provided text, a comprehensive description of acceptance criteria and the full study results is not available. The documents are an FDA clearance letter and the "Indications For Use" statement, which refer to a study that was submitted as part of the 510(k) application (K981134). The specific details of that study are not included in these excerpts.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred/Expected for MIC devices)	Reported Device Performance (Not explicitly stated in provided document)
Essential Agreement (EA) with reference method	Not explicitly stated. Typically, a high percentage (e.g., >90-95%) of results should be within ±1 doubling dilution of the reference method MIC.
Category Agreement (CA) with reference method	Not explicitly stated. Typically, a high percentage (e.g., >90-95%) of results should have the same susceptibility category (Susceptible, Intermediate, Resistant) as the reference method.
Major Discrepancies (MD) rate	Not explicitly stated. MDs (Resistant by test, Susceptible by reference) should be low (e.g., <3%).
Very Major Discrepancies (VMD) rate	Not explicitly stated. VMDs (Susceptible by test, Resistant by reference) should be very low (e.g., <1.5%).
Reproducibility/Precision	Not explicitly stated. The device should consistently produce similar results when tested repeatedly.
Accuracy across target MIC range (0.016 - 256 µg/ml)	Not explicitly stated, but the indication mentions this range.

Note: The provided FDA letter states "we have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the performance data submitted for Etest® Tetracycline met the FDA's criteria to demonstrate equivalence to existing, legally marketed Tetracycline susceptibility tests, likely by achieving agreement rates (Essential Agreement, Category Agreement, and acceptable discrepancy rates) similar to or better than previously cleared devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided documents.
Data Provenance: Not explicitly stated (e e.g., country of origin, retrospective or prospective). However, clinical studies for medical devices are typically prospective, but retrospective data can also be used for certain aspects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. For antimicrobial susceptibility testing, the "ground truth" (reference method results) is typically established by trained microbiologists following standardized laboratory procedures (e.g., NCCLS/CLSI guidelines) for a well-characterized reference MIC method (e.g., broth microdilution or agar dilution).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or explicitly stated. For MIC determination, the reference method provides a quantitative result. Discrepancies are usually analyzed against this reference, rather than adjudicated by multiple human readers in the same way imaging studies might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No, an MRMC study is not typically applicable for automated/semi-automated in vitro diagnostic devices like Etest for MIC determination. MRMC studies are common for diagnostic imaging AI systems where human readers interpret images with and without AI assistance. The Etest directly provides an MIC result, reducing the variability associated with human interpretation.
Effect Size of Human Readers with/without AI Assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Study Done: Yes, implicitly. The performance data submitted for Etest® Tetracycline would represent its "standalone" performance against a reference method. Etest itself is a device that produces a result (MIC) which is then interpreted by a trained microbiologist. The "algorithm" here is the physical gradient strip and the chemical properties that produce the elliptical inhibition zone, which is then measured. The evaluation would be on how accurately this method determines the MIC compared to a gold standard.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for antimicrobial susceptibility testing is typically established by a reference Minimum Inhibitory Concentration (MIC) method, such as broth microdilution or agar dilution, performed according to recognized standards (e.g., National Committee for Clinical Laboratory Standards [NCCLS], now Clinical and Laboratory Standards Institute [CLSI]). This is considered the "gold standard" for determining the susceptibility of bacteria to antibiotics.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. Etest is a phenotypic test, not an AI/ML algorithm in the modern sense that requires a "training set" of data in the same way. Its design is based on established principles of antibiotic diffusion. However, internal development and optimization of the strip's gradient would involve extensive testing. If "training set" refers to the initial validation data used during product development (prior to the submission of the Pivotal/Confirmatory study), that information is not present.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable in the context of an AI/ML "training set" for Etest. If "training set" refers to the development phase, the ground truth would have been established using the same reference MIC methods as described in point 7.

Summary of Missing Information:

The provided documents, being a 510(k) clearance letter and an "Indications For Use" statement, primarily confirm the device's clearance and intended use. They do not contain the detailed study report that would specify:

The exact sample sizes for testing.
The raw performance data (Essential Agreement, Category Agreement, discrepancy rates).
Details of the specific reference methods used.
The data provenance (e.g., country, study centers).
Any specifics about the development process or validation prior to the pivotal submission study.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird in flight. The image is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 8 1998

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

Re: K981134 Trade Name: Etest® Tetracycline Regulatory Class: II Product Code: JWY Dated: March 26, 1998 Received: March 30, 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 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.

{1}------------------------------------------------

Page 2

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

{2}------------------------------------------------

510(k) Number (if known): #973459/A K 98 / / 34

Device Name: Etest® Tetracycline

Indications For Use:

For in vitro diagnostic use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubais

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981134

Use ✗

Over-The Counter Use

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Image /page/2/Picture/12 description: The image shows a black circle on a white background. The circle is not perfectly uniform, with some irregularities and variations in its edge. The black color of the circle is solid, and the white background provides a stark contrast. The circle is positioned in the image so that it is slightly cut off on the left side.

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).