(268 days)
The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of verotoxins Fand if (Onlya like toking) produced by E. coli isolated in cultures derived promotion aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.
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The provided document is a 510(k) clearance letter from the FDA for the Duopath® Verotoxins GLISA test. This type of document primarily confirms that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics (or different ones that do not raise new questions of safety or effectiveness).
Crucially, this document does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a full submission with clinical or analytical performance studies. The clearance letter references the 510(k) submission (K031367) which would contain this information, but the submission itself is not provided here.
Therefore, many of the requested details cannot be extracted from the given text.
Here's what can be inferred and what cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the FDA's acceptance criteria for substantial equivalence were met, and the performance data within the submission supported this. However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and the reported performance values are not present in this letter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot provide. This information would be found in the detailed study report within the 510(k) submission, not in the clearance letter.
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)
- Cannot provide. This information is not typically part of the FDA clearance letter, but rather in the study design documentation. For an in vitro diagnostic like this, the "ground truth" often comes from a reference culture method or a highly characterized strain rather than human expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot provide. Adjudication methods are relevant for studies where human interpretation of results has variability, especially in imaging. For a GLISA test (an immunoassay), the "ground truth" is typically established via laboratory methods, not expert adjudication in the same sense as an imaging study.
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 / Cannot provide. MRMC studies are specific to imaging devices where human readers interpret medical images, sometimes aided by AI. The Duopath® Verotoxins GLISA test is an in vitro diagnostic test, not an imaging device, and does not involve AI assistance for human image interpretation. Therefore, an MRMC study or AI assistance effect size is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot provide. As an in vitro diagnostic test, the "algorithm only" concept (as it pertains to AI/software) doesn't directly apply. The GLISA test is a standalone diagnostic kit with a defined protocol and reagents. Its performance is evaluated on its ability to detect specific analytes. Whether the interpretation of that test involves a human 'in the loop' is a separate question, but not in the same sense as an AI algorithm processing data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred based on device type: For an in vitro diagnostic test like the Duopath® Verotoxins GLISA, the most common type of ground truth would be reference culture methods, PCR, or highly characterized bacterial strains known to produce (or not produce) Verotoxins. This would be established by microbiological laboratory techniques, not expert consensus or pathology in the clinical sense. The specific methodology would be detailed in the 510(k) submission.
8. The sample size for the training set
- Not applicable / Cannot provide. This device is an in vitro diagnostic kit, not a machine learning or AI model that requires a "training set" in the computational sense. Its design and validation rely on analytical studies (e.g., specificity, sensitivity, cross-reactivity) using known samples, not on a machine learning training paradigm.
9. How the ground truth for the training set was established
- Not applicable / Cannot provide. (See point 8).
In Summary:
The provided document is a regulatory clearance letter. It confirms the FDA's determination of substantial equivalence for the Duopath® Verotoxins GLISA test. It does not include the detailed performance study results, acceptance criteria, sample sizes, or methodologies for ground truth establishment, which would be part of the full 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 3 2004
Ms. Anna G. Bentley Vice President, RA/QA EMD Chemicals Inc. 480 South Democrat Road Gibbstown, NJ 08027
Re: K031367
Trade/Device Name: Duopath® Verotoxins GLISA test Regulation Number: 21 CFR 866.3255 Regulation Name: Escherichia coli serological reagents Regulatory Class: Class I Product Code: GNA Dated: January 19, 2004 Received: January 20, 2004
Dear Ms. Bentley:
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 complics 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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.
Sarantis
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
KO31367 510(k) Number (if known):
Duopath® Verotoxin GLISA Test Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of The Duopath® Verotoxins) produced by E. coli isolated in cultures derived verotoxins Fand if (Onlya like toking) promotion aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.
Prescription Use (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)
Division Sign-Off
Tegart
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko 3, 3i]
§ 866.3255
Escherichia coli serological reagents.(a)
Identification. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genusEscherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.