(60 days)
Pyloriset EIA-G is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori. The product is intended for use to test patients with symptoms of gastrointestinal disorders.
Pyloriset EIA-G is a qualitative enzyme immunoassay.
The provided text is a 510(k) clearance letter for the Pyloriset EIA-G device and contains limited information regarding performance studies. Based on the available text, I can infer some details, but much of the requested information is not present.
Here's an attempt to answer your questions based only on the provided text, with clear indications where information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance. It only indicates that the device has been found "substantially equivalent" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text.
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)
This information is not available in the provided text. The device is for "detection of Helicobacter pylori specific IgG antibodies in human serum," which typically relies on laboratory-based ground truth (e.g., culture, biopsy, or other validated H. pylori tests), not necessarily expert human review of images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided text. Given it's an immunoassay, human adjudication in the traditional sense for image interpretation would not apply. Ground truth would be established by laboratory methods.
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
This is an immunoassay for detecting antibodies, not an AI-powered diagnostic imaging device. Therefore, an MRMC study and its associated effect size on human readers are not applicable and not mentioned in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Pyloriset EIA-G is described as a "qualitative enzyme immunoassay." As an immunoassay, its performance is inherently "standalone" in the sense that it provides a result based on the chemical reaction. Performance studies for such devices typically evaluate their accuracy, sensitivity, and specificity against a gold standard, which would constitute standalone performance. However, specific details of such a study are not provided in the text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states the device "is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori." For a device like this, the ground truth would typically be established through highly accurate and accepted methods for H. pylori infection diagnosis, such as:
- Histopathology (biopsy with identification of H. pylori)
- Culture of H. pylori from biopsy
- Urea breath test or stool antigen test (which are highly accurate for active infection)
- A combination of these or a validated reference assay.
However, the exact type of ground truth used in the studies for this specific device is not explicitly stated in the provided text.
8. The sample size for the training set
The provided text describes a 510(k) clearance letter for an immunoassay. The concept of a "training set" is primarily relevant to machine learning/AI algorithms. Immunoassays are based on biochemical reactions and do not typically involve "training sets" in the same way. The development and validation of an immunoassay involve optimizing reagents and protocols, and then testing on clinical samples. The sample size and methodology for such validation are not available in the provided text.
9. How the ground truth for the training set was established
As with point 8, the concept of a "training set" for an immunoassay is not directly analogous to AI. Therefore, how ground truth for a "training set" was established is not applicable and not mentioned in the provided text. The ground truth for the clinical samples used in the performance study (if described) would be established by methods mentioned in point 7.
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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 consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
JUN 27 1997
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annikka Rantama Assistant Vice President Quality Assurance & Regulatory Affairs Orion Diagnostica Koivumankkaan Tie 6 Espoo, Finland 02200
K971537 Re: Trade Name: Pyloriset EIA-G Requlatory Class: I Product Code: LYR 83 April 15, 1997 Dated: Received: April 28, 1997
Dear Ms. Rantama:
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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 regulationy In addition, FDA may publish further announcements action. 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 Requlations.
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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 Butman
Steven I. Gutman, M.D., M.B.A. Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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April 15, 1997
B.
1(1)
Premarket Notification
Product: Pyloriset EIA-G . . . . . . - -- -
Indication for use
Pyloriset EIA-G is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori. The product is intended for use to test patients with symptoms of gastrointestinal disorders.
Product Classification:
)
LYR Product code: Classification panel: Microbiology (83) Device class: Class I
Aa Pi
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices
510(k) Number K971537
✓ Prescription use
Over the County
§ 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).