PYLORI DETECT IGG by MICRO DETECT, INC.

The PYLORI DETECT IgG is a qualitative Enzyme Immunoassay( EIA) Kit for the detection of IgG antibodies against H. pylori in human serum. The test is intended as an aid in the diagnosis of infection by H. pylori in patients with gastrointestinal symptoms. FOR IN VITRO DIAGNOSTIC USE ONLY.

Device Description

The Micro Detect, Inc. H. pylori reagent ( PYLORI DETECT IgG) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution. The Micro plate ELISA formats is a commonly used format for the detection of many entities of clinical interest, including infectious diseases.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pylori Detect IgG device, based on the provided documents:

Acceptance Criteria and Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	Not explicitly stated	98.3%
Specificity	Not explicitly stated	94.4%
Positive Predictive Value	Not explicitly stated	97.0%
Negative Predictive Value	Not explicitly stated	96.7%
Accuracy	Not explicitly stated	[Missing from document - garbled text]
Inter-assay Precision (CV)	Not explicitly stated	1.39-5.91%
Intra-assay Precision (CV)	Not explicitly stated	4.35-6.86%
Stability	1 year at 2-8°C	1 year at 2-8°C

Note: The document states "The patient results obtained using the PYLORI DETECT IgG are substantially equivalent to those obtained by endoscopic evaluations." This implies that the metrics listed (Sensitivity, Specificity, PPV, NPV, Accuracy) were based on comparison to endoscopic evaluations as the gold standard, and the reported values met what was considered "substantially equivalent." However, specific numerical acceptance criteria are not explicitly defined in the provided text. The "Accuracy" metric in the provided text is garbled.

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. The document refers to "patient results" but does not specify the country of origin or whether the data was retrospective or prospective.
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):
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth method is "endoscopic evaluations," which would typically be performed and interpreted by medical professionals (e.g., gastroenterologists), but the number or specific qualifications are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth appears to be based on a singular diagnostic method ("endoscopic evaluations") rather than an expert consensus process requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA kit) for detecting antibodies, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was performed. The reported performance metrics (Sensitivity, Specificity, etc.) represent the performance of the PYLORI DETECT IgG assay system itself, as a "manual procedure" without human interpretative intervention beyond performing the assay according to instructions. The device directly produces results for IgG antibodies.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Endoscopic evaluations. The document states: "The patient results obtained using the PYLORI DETECT IgG are substantially equivalent to those obtained by endoscopic evaluations". This implies endoscopy was the reference standard for diagnosing H. pylori infection.
The sample size for the training set:
- Not explicitly stated. The document describes a "510(k) Safety and Effectiveness Information" summary, which focuses on validation data rather than the development of the assay.
How the ground truth for the training set was established:
- Not explicitly stated, as details regarding a training set are absent from the provided "Safety and Effectiveness Information."

Summary

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MAR 1 0 1998

SUMMARY OF 510 (k) SAFETY AND EFFECTIVENESS INFORMATION

This summary of 510 (k) safety and effectivencss information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

Micro Detect, Inc. PYLORI DETECT IgG reagents (P/Nxxxxxxx) is intended for the qualitative determination of IgG antibodies to H pylori in human serum. The principal diagnostic value of the presence of these antibodies in serum is detection of H. pylori intection, which is used as an aid in patients with Peptic and Duodenal ulcers.

The Micro Detect, Inc. H. pylori reagent ( PYLORI DETECT IgG) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific autigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

The patient results obtained using the PYLORI JJHTF.CT IgG are substantially equivalent to those obtained by endoscopic evaluations:

Sensitivity:	98.3%
Specificity:	94.4 %
Positive predictive value:	97.0 %
Negative predictive value: 96.7 %
Accuracy:	વેર જે જે જે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી

Precision: 1.39-5.91(Inter) and 4.35-6.86(Intra)

Stability: One year at 2-8°C. The stability of the PYLORI DETECT IgG Kit for the detection of IgG antibodies to H pylori was found to be one year at 2-8°C. This was predicted from studies done under stress condition (37°C). Real time stability is being monitored at 2-8°C.

The Micro plate ELISA formats is a commonly used formal for the detection of many entities of clinical interest, including infectious diseases.

The PYLORI DETECT IgG assay system is shown to be safe and effective and provide patients results which are substantially equivalent to those obtained by endoscopic cvaluations.

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MAR 1 0 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mehdi Alem, Ph.D. General Manager Micro Detect, Inc. 23016 Del Lago Dr., Suite B Laguna Hills, CA 92653

Re: K973508 Trade Name: Pylori Detect IgG Regulatory Class: I Product Code: LYR - ---Dated: December 19, 1997 Received: December 29, 1997

Dear Dr. Alem:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeline, 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.

Image /page/1/Picture/9 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

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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 vours.

Steven Autman

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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K973508/A'

Page 1 of 1

K97350 8 510(k) Number (if known):___ PYLORI DETECT Device Name:_ IGG

Indications For Use:

The PYLORI DETECT IgG is a quallefative Enzyme Immunoassay( EIA) Kit for the detection of IgG antibodies against H. pylori in human serum. The test is intended as
an aid in the diagnosis of infection by H. puber in The test is intended as an aid in the diagnosis of infection by H. pylori in patients with gastroned as
an aid in the diagnosis of infection by H. pylori in patients with gastronestinal symptoms. FOR IN VITRO DIAGNOSTIC USE ONLY.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K973508

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

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).