(104 days)
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No
The description details a standard ELISA test and microtiter plate reader, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
This device is an ELISA test for diagnostic purposes (detection of antibodies), not a therapeutic intervention.
Yes
The intended use explicitly states "as an aid in the diagnosis of H. pylori infection."
No
The device description clearly states it is an ELISA test, which is a laboratory-based assay involving physical reagents and a microtiter plate reader instrument. This indicates it is a hardware-based diagnostic test, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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". This describes a test performed on a biological sample (serum) outside of the body to provide information for diagnosis.
- Device Description: The device description reinforces this by stating it's an "ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori".
- Sample Type: The test uses "serum", which is a biological sample.
- Testing Location: The tests are carried out in "clinical laboratories", which is a typical setting for IVD testing.
- Intended User: The intended users are "laboratory technologists / technicians", who are trained professionals performing laboratory tests.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LYR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
clinical laboratories by laboratory technologists / technicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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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Image /page/2/Picture/0 description: The image shows a logo with the letters "AMDL" arranged horizontally. The letters are positioned within a circular design, where the top half of the circle is incomplete, creating an opening above the letters. The letters "AMDL" are in a serif font, and the circular design consists of two concentric circles, with the space between them filled in black, giving it a bold appearance.
INTENDED USE AND INDICATIONS STATEMENT
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.
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