The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.

Device Description

As the sample flows laterally through the membrane, the specific antibody bindingprotein dye conjugate binds to the human immunoglobulins in the sample. If the sample contains IgG antibodies to H. pylori, the complex binds to the antigens on the solid phase of the device's test region producing a red/pink (red) line. In the absence of H. pylori antibodies, no line appears in the test region of the device. A procedural-functional control is built in to each device. As the sample migrates across the control region, the appearance of a red line at the control region indicates correct procedure and a functional device.

AI/ML Overview

This document describes the Uni-Gold™ H. pylori test kit, a rapid in-vitro qualitative immunoassay for detecting IgG antibodies to Helicobacter pylori in adult human serum, plasma, or whole blood.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

While explicit acceptance criteria are not stated as numerical thresholds (e.g., "sensitivity must be >X%"), the study's goal was to demonstrate "substantial equivalence" and "accuracy." Given the results, it can be inferred that performance around these reported accuracy metrics was deemed acceptable by the FDA for substantial equivalence to the predicate device.

Performance Metric	Implied Acceptance Criteria (Inferred from Study Results)	Reported Device Performance (Uni-Gold™ H. pylori test kit)
Clinical Sensitivity	(Not explicitly stated, but around 83%)	83% (136/164 positive samples correctly identified)
Clinical Specificity	(Not explicitly stated, but around 83%)	83% (152/184 negative samples correctly identified)
Overall Accuracy	(Not explicitly stated, but around 83%)	83%
Cross-Reactivity	No cross-reactivity with tested organisms and substances	No cross-reactivity observed
Sample Stability	Accurate results within specified storage conditions	Accurate for serum/plasma at 2-8℃ for 3 days; -20°C longer
Hematocrit Effects	Accurate results within physiological range	Accurate with hematocrits 39% to 53%
Matrix Equivalence	Equivalent results across matrices	Equivalent results in whole blood, serum, and plasma

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 348 clinical samples (164 positive and 184 negative based on biopsy results).
Data Provenance: The clinical trials were performed at three independent sites in the USA, Canada, and Sweden. This indicates a prospective and multi-site collection with a mixed population (race, sex, age) of patients presenting with gastrointestinal symptoms.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish the ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the ground truth was established by "gastric biopsy for culture and histology for the detection of H. pylori infection." This implies medical professionals (pathologists, microbiologists) involved in the analysis of these biopsy samples.

4. Adjudication Method for the Test Set

The adjudication method for the biopsy results (ground truth) was defined as follows:

Biopsy "positive": Culture and histology positive OR culture positive.
Biopsy "negative": Negative for both culture and histology OR negative for culture.

This is a specific rule-based adjudication method rather than an expert consensus voting method (like 2+1 or 3+1). It establishes a clear hierarchy and condition for positivity and negativity based on multiple diagnostic tests.

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

No MRMC comparative effectiveness study was mentioned. This device is a rapid diagnostic test kit, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting images. Therefore, the concept of human readers improving with or without AI assistance does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The Uni-Gold™ H. pylori test kit is a physical diagnostic device, and its performance (sensitivity, specificity, accuracy) was evaluated independently against the biopsy gold standard. There is no "human-in-the-loop" once the sample is applied and the test runs; the interpretation is visual (presence/absence of a red line) and inherent to the device's design.

7. The Type of Ground Truth Used

The primary ground truth used was biopsy results, specifically defined as:

Biopsy positive: Culture and histology positive OR culture positive.
Biopsy negative: Negative for both culture and histology OR negative for culture.

Additionally, an ELISA assay was used to evaluate 60 discrepant results between the Uni-Gold™ test and the biopsy, indicating a secondary, corroborative ground truth in ambiguous cases, although the primary ground truth remained the biopsy.

8. The Sample Size for the Training Set

The document does not provide information on a separate training set. For rapid diagnostic test kits like this, the development process typically involves internal optimization and validation with various panels of known positive and negative samples, rather than a distinct "training set" in the machine learning sense. The 348 clinical samples tested are referred to as the "clinical data" used to determine the device's accuracy, essentially serving as a validation or test set.

9. How the Ground Truth for the Training Set Was Established

As no explicit training set is identified, the method for establishing its ground truth is not described. However, it can be inferred that any samples used during the development and optimization phases would have had their H. pylori status confirmed by established laboratory methods, likely similar to or including culture, histology, or reference serological tests.

Summary

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K991697

Image /page/0/Picture/1 description: The image shows the logo for Trinity Biotech. The word "Trinity" is in bold, white letters against a black triangle. Below that, the word "biotech" is in smaller, black letters.

Trinity Biotech plc. IDA Business Park. Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888 e-mail: info@trinitybiotech.ie.

510(k) SUMMARY

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

The assigned 510(k) number is: K991697.

DEC 2 1 1999

Submitter Information (21 CFR 807.92(a)(1)) Trinity Biotech, plc Submitter: IDA Business Park Bray

Contact:

Dr. Jim Walsh Chief Operating Officer Trinity Biotech, plc phone: 011 353 1 276 9800 fax: 011 353 1 276 9888

County Wicklow, Ireland

November 5, 1999 Summary Date:

Name of Device and Classification (21 CFR 807.92(a)(2)) Name (trade): Uni-Gold™ H. pylori test kit

Name (usual): Helicobacter pylori serological reagents

Classification: 21 CFR 866.3110, Class I, LYR

Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3)) The Uni-Gold H. pylori test kit is substantially equivalent to the Quidel QuickVue One-Step H. pylori Test (QuickVue), Quidel Corporation, San Diego, CA. The Uni-Gold H. pylori test kit is identical, or similar to, its predicate in terms of: intended use, antibodies detected, technology/methodology, testing matrices, and result interpretation.

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Description of Device (21 CFR 807.92 (a)(4))

Intended Use (21 CFR 807.92 (a)(5))

Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))

A summary table of the similarities and differences between the Uni-Gold H. pylori test kit and the predicate device (QuickVue) follows.

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CHARACTERISTIC	UNI-GOLD™ H. PYLORI	QUICKVUE
Intended Use	immunoassay for the rapidqualitative detection of IgGHelicobacter pylori antibodiesin adult human whole blood,serum, or plasma. The test isintended for professional use inphysicians' offices and hospitallaboratories as an aid in thediagnosis of H. pylori infectionin patients with clinical signsand symptoms ofgastrointestinal disease.	immunoassay for the rapid,qualitative detection of IgGantibodies specific toHelicobacter pylori in humanserum, plasma, or wholeblood as an aid in thediagnosis of H. pyloriinfection in patients withclinical signs and symptomsof gastrointestinal disease.The test is intended forprofessional/laboratory use.
Antibodies Detected	Helicobacter pylori	Helicobacter pylori
Methodology/Technology	As the sample flows laterallythrough the membrane, thespecific antibody binding-protein dye conjugate binds tothe human immunoglobulins inthe sample. If the samplecontains IgG antibodies to H.pylori , the complex binds to theantigens on the solid phase ofthe device's test regionproducing a red/pink (red) line.In the absence of H. pyloriantibodies, no line appears in thetest region of the device. Aprocedural-functional control isbuilt in to each device. As thesample migrates across thecontrol region, the appearance ofa red line at the control regionindicates correct procedure and afunctional device.	Sample flows through a padcontaining purified H. pyloriantigen coupled to red beadsand blue control beads. If thesample contains H. pylorispecific IgG antibody, it willbind to the antigen coupled tothe red beads, which, in turn,will bind to a monoclonalanti-human IgG antibodyspotted on the membrane. Asthe H. pylori antigen-antibodycomplex is captured, a redTest Line will appear in theResult Window. A blueProcedural Control Line willalso appear if proper fluidvolume entered the deviceand capillary flow occurred.If H. pylori IgG antibody isnot present, or is present atvery low levels, only a blueControl Line will be visible.
Testing Matrices	whole blood, serum, plasma	whole blood, serum, plasma
Result Interpretation	positive or negative forH. pylori antibodies	positive or negative forH. pylori antibodies
Assay Read Time	10 minutes	10 minutes
CHARACTERISTIC	UNI-GOLD H. PYLORI	QUICKVUE
Assay Procedure	1 drop of sample followed by 3 drops of wash	3 drops of sample
Sample Volume	30 $\mu$ L	>100 $\mu$ L
Storage Temperature	2-27° C	15-30° C

Similarities Between Uni-Gold™ H. pylori test kit and QuickVue

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Differences Between Uni-Gold H. pylori Test Kit and QuickVue

Brief Discussion of Nonclinical Data (21 CFR 807.92(b)(1))

Studies were conducted to evaluate cross reactivity, effects of hematocrit, sample stability, and test performance in various matrices (whole blood [fingerstick and venous], serum, and plasma).

No cross reactivity was observed with the testing of the following organisms: Campylobacter jejuni, Campylobacter coli, Campylobacter fetus, and Escherichia. coli, and Borrelia burgdorferi antibodies (Lyme disease positive samples). Further, there was no effect from the addition of very high levels of bilirubin, albumin, and hemoglobin.

The Uni-Gold™ H. pylori assay provided accurate results with hematocrits ranging from 39% to 53%.

Serum and plasma samples may be assayed when stored at 2-8℃ for up to three days, and when stored frozen at -20°C for longer intervals. Also, there were equivalent results in whole blood, serum, and plasma matrices.

Brief Discussion of Clinical Data (21 CFR 807.92 (b)(2)

The clinical sensitivity and specificity (accuracy) of the Uni-Gold™ H. pylori test kit was determined by the analysis of 348 clinical samples (164 positive and 184 negative) at three independent sites (USA, Canada, and Sweden). The clinical trials were performed on patients of mixed populations of race, sex, and age who presented with various gastrointestinal symptoms.

All patients underwent venipuncture for detection of antibodies to H. pylori by the Uni-Gold™ H. pylori test kit, and a commercially available ELISA kit, as well as gastric biopsy for culture and histology for the detection of H. pylori infection. Biopsy "positive" was defined as culture and histology positive or culture positive, and biopsy "negative" was defined as negative for both culture and histology, or negative for culture. Biopsy results were considered the gold standard reference results for the detection of active H. pylori infection. The results are summarized below.

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n = 348 samples		Biopsy		Results
		+	-	+	-
Uni-Gold™ H. pylori	+	136			32
	-	28			152
Reference Totals		164			184

Uni-Gold™ H. pvlori Test Kit Results vs Biopsy Results

The data demonstrated the Uni-Gold™ H. pylori test kit correctly identified 136 of the 164 biopsy-positive samples for a sensitivity of 83%, and correctly identified 152 of 184 biopsy-negative samples for a specificity of 83%. The overall accuracy was 83%.

Uni-Gold™ H. pylori test kit Vs Biopsy In Conjunction with ELISA

ELISA results were used to evaluate the 60 discrepant results (28 false negative and 32 false positive) between the Uni-Gold H. pylori test kit and biopsy. The ELISA method detects the presence of human IgG antibodies to H. pylori, and the ELISA testing was performed on all samples (* sample volume permitting).

only 52 of the 60 results are reported as there was either insufficient sample for ELISA testing, or ELISA results were inconclusive.

The data indicate that, of the 52 available results, 20 were found to be positive by both the Uni-Gold™ H. pylori test and ELISA, and five were found to be negative by both methods.

Performance Data - Conclusions (21 CFR 807.92 (b)(3))

The studies demonstrated the substantial equivalence of the Uni-Gold™ H. pylori test kit to existing products already marketed. Cross-reactivity studies confirmed the specificity of the assay, and clinical studies confirmed the assay's accuracy.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

DEC 2 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Trinity Biotech, plc c/o Ms. Erika B. Ammirati, RAC, MT(ASCP) Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, California 94022

Re: K991697 Trade Name: Uni-Gold™ H. pylori Regulatory Class: I Product Code: LYR Dated: November 5, 1999 Received: November 8, 1999

Dear Ms. Ammirati:

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 (OS) 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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Page 2

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 vour 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 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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Page_1_of_1

510(k) Number (if known): K991697

Device Name:_Uni-Gold™ H. pylori

Indications For Use:

The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in-vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L.M. Poole acting for W.R. Dubois;

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991697

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(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).