DAPTOMYCIN by AB BIODISK | FDA 510(k) Summary

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation. (Original FDA clearance for Etest - file K913459/A)

This Etest 510(k) submission is for an additional antibiotic i.c. Etest for MIC deemination of This Etest 310(K) Submission is 10.016 - 256 µg/ml with E. faecalis and E. Jaeium (vancomycin-Daptomyen in the MIC faires of over including methicillin resistant strains), coagulase negative Staphylococcus spp. and ß-haemolytic Streptococcus spp.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a new Etest® Daptomycin antimicrobial susceptibility test. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've requested for typical AI/diagnostic device applications.

The provided text is a regulatory clearance document, not a detailed study report. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information you're asking for (e.g., sample sizes, expert qualifications, study methodologies, performance metrics like sensitivity/specificity) is usually found in a separate clinical study report, which is typically summarized in the 510(k) submission but not fully detailed in the clearance letter itself.

Therefore, I cannot populate the table or answer the specific questions based only on the text provided because it does not contain that level of detail.

However, I can tell you what is typically expected for such a device in terms of performance and how its substantial equivalence would have been established, based on the nature of antimicrobial susceptibility testing (AST) devices.

For AST devices like the Etest®, "acceptance criteria" usually refer to agreement rates with a reference method (e.g., broth microdilution or agar dilution). The "study" would be a clinical study comparing the Etest® results to these reference methods.

Here's how I would hypothetically complete your request for an AST device, based on common FDA requirements for such submissions, and indicate what is not present in the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Device: Etest® Daptomycin 0.016-256 µg/mL

Intended Use: For in vitro diagnostic use to determine the minimum inhibitory concentration (MIC) of Daptomycin for specific bacterial species (E. faecalis, E. faecium, Staphylococcus spp., Streptococcus spp.).

This 510(k) clearance letter from the FDA indicates that the Etest® Daptomycin has been found substantially equivalent to a legally marketed predicate device. While the provided document does not contain the detailed study results or explicit acceptance criteria, for antimicrobial susceptibility testing (AST) devices, the performance is typically evaluated by comparing results to a recognized reference method.

Hypothetical Acceptance Criteria and Reported Device Performance (Based on typical AST device standards):

Performance Metric	Acceptance Criteria (Hypothetical)	Reported Device Performance (Not in document, but would be from a study)
Essential Agreement (EA)	≥ 90% (Agreement within ±1 dilution of reference MIC)	[e.g., >95%]
Categoryal Agreement (CA)	≥ 90% (Agreement on result interpretation: Susceptible, Intermediate, Resistant)	[e.g., >95%]
Minor Discrepancies	≤ 7% (e.g., device S / reference I, or device I / reference S/R)	[e.g., <5%]
Major Discrepancies	≤ 3% (e.g., device S / reference R)	[e.g., <2%]
Very Major Discrepancies	≤ 1.5% (e.g., device R / reference S)	[e.g., <1%]
Reproducibility	Consistent results across different testing sites/batches	[Confirmed]

Detailed Study Information (Based on common AST device studies – not available in the provided document):

Sample size used for the test set and the data provenance:
- Sample Size: This information is not present in the document. Typically, hundreds to thousands of isolates covering the relevant species and resistance mechanisms would be tested.
- Data Provenance: This information is not present in the document. Clinical isolates would be collected from diverse geographical regions (e.g., USA, Europe) and could be a mix of retrospective and prospectively collected strains, often including challenge strains with known resistance phenotypes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Ground Truth Method: This information is not present in the document. For AST devices, the "ground truth" is typically established by a reference method (e.g., CLSI-recommended broth microdilution or agar dilution) performed by trained microbiologists, rather than a consensus of experts interpreting images or complex data. The interpretation of the reference method's MIC value into categorical results (S/I/R) is based on established clinical breakpoints (e.g., CLSI guidelines).
Adjudication method for the test set:
- Adjudication Method: This information is not present in the document. Discrepancies between the candidate device and the reference method would typically be adjudicated by repeat testing on both the candidate device and the reference method, or by using an alternative reference method, performed by experienced microbiologists.
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:
- MRMC Study: No. This type of study (MRMC for AI assistance) is not relevant for this device. Etest® is a manual, interpretive test where a trained microbiologist reads the MIC value directly; it is not an AI-powered image analysis or diagnostic support tool. The comparison is between the device's output and a reference method's output, not human performance with/without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of AI. Etest® is a manual test and requires a human to interpret the ellipse and read the MIC value. Its performance is directly tied to this human interpretation, albeit a standardized one.
The type of ground truth used:
- Ground Truth Type: This information is not explicitly stated but for AST devices, the ground truth is established by a reference method, such as broth microdilution or agar dilution, performed according to recognized standards (e.g., CLSI M07 guidelines).
The sample size for the training set:
- Training Set Sample Size: Not applicable. Etest® is a phenotypic test method based on diffusion gradients, not a machine learning model that requires a "training set." The methodology is predetermined.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable (as above).

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 3 2004

Ms. Anne Bolmström President & CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden

K042392 Re:

Trade/Device Name: Etest® Daptomycin 0.016-256 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: December 3, 2004 Received: December 3, 2004

Dear Ms. Bolmström:

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. 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogen mailioning of substantial equivalence of your device to a legally prematics notification: The PDF Americation for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific monitiation and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In Pill o Diagnostic Dorloo Drarance to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saqartys

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K042392

Device Name: Etest® Daptomycin 0.016-256 µg/mL

Indications For Use:

For in vitro diagnostic use:

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below This Line-continue on another Page IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Luddie L. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Saicty

510(k)

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C:\Documents and Settings\MBB\Desktop\OlVD\Review AST 510K\AB Biodisk\Daptomycin k042392le-mail 1104\IFU 0411.DOC

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).