PYLORIPROBE by AMDL, INC. | FDA 510(k) Summary

PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test is not to be used with asymptomatic patients. The tests are carried out in clinical laboratories by laboratory technologists / technicians and the test results are measured in a microtiter plate reader instrument.

Device Description

PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori.

AI/ML Overview

This FDA letter for K981396, "PyloriProbeTM," does not contain the detailed information necessary to answer the questions about acceptance criteria and the study proving device performance as typically expected for medical device submissions. This letter is a 510(k) clearance, which confirms substantial equivalence to a predicate device, rather than a full review of a new clinical study.

Therefore, many of the requested details are not available in the provided document.

However, based on the information present, here's what can be extracted and noted regarding the lack of other information:

1. A table of acceptance criteria and the reported device performance

Not Available. The document is a 510(k) clearance letter and does not include performance data or specific acceptance criteria. It only states that the device is "substantially equivalent" to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. The document does not provide details about a test set sample size or its provenance.

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 Available. The document does not describe the establishment of a ground truth for a test set or the involvement of experts in that process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Available. The document does not mention any adjudication methods for a test set.

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 Available. The PyloriProbeTM is an ELISA test for the detection of H. pylori antibodies, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study with AI assistance is not relevant to this device type. The document does not mention any comparative effectiveness studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Available. This device is an in vitro diagnostic (IVD) ELISA test that is performed and interpreted by laboratory technologists/technicians. It is not an algorithm-only device. The document does not detail performance studies for the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Available. The document does not specify the type of ground truth used for any performance evaluation. For an IVD like this, ground truth would typically be established through other definitive diagnostic methods for H. pylori infection (e.g., biopsy, culture, urea breath test) against which the ELISA results are compared.

8. The sample size for the training set

Not Available. The document does not provide information about a training set since this is a 510(k) clearance for an IVD test, not a submission for an AI/machine learning model.

9. How the ground truth for the training set was established

Not Available. As above, no training set is discussed or implied by the document's content.

In summary, the provided FDA 510(k) clearance letter focuses on the regulatory determination of substantial equivalence rather than on detailed performance study results that would contain the requested information. To find such details, one would typically need to review the full 510(k) submission summary or detailed results from the manufacturer (AMDL, Inc.).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 30 1998

That T. Ngo, Ph.D. President & CEO AMDL, Inc. 14272 Franklin Avenue, Suite 106 Tustin, CA 92780-7017

Re: K981396 Trade Name: PyloriProbeTM Regulatory Class: I Product Code: LYR Dated: June 19, 1998 Received: June 23, 1998

Dear Dr. Ngo:

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 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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INTENDED USE AND INDICATIONS STATEMENT

Hengst

That T. Ngo President & CEO

Date

June 11, 1998

Perry Rucker

Manager, Regulatory Affairs

6-11-98

Date

Woody Deebais

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981396

AMDL, Inc. 14272 Franklin Avenue, Suite 106 Tustin, CA 92780-7017 (714)505-4460 Fax (714)505-4464 http://www.amdl.com E-mail address amdl@aol.amdl.com

Regulation Number and Section

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).