The ACON® H. pylori Rapid Test Strip and ACON® H. pylori Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of antibodies specific to H. pylori in human whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for healthcare professionals and professionals at point of care sites only.

Device Description

The ACON® H. pylori rapid Test Strip and ACON® H. pylori rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood, serum or plasma. They utilize H. pylori antigen coated particles and immobilized anti-human IgG to selectively detect elevated levels of IgG antibodies to H. pylori. These tests can be performed without the use of an instrument.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices and the clinical performance data provided. The device aims to demonstrate "substantial equivalence" to the predicate devices. The performance is reported as agreements (positive, negative, and overall) with predicate devices, and sensitivity, specificity, and accuracy against "Culture/Histology" and "Histology/Rapid Urease Test" as the ground truth.

ACON® H. pylori Rapid Test Strip:

Acceptance Criteria (Implied by Predicate Devices / Ground Truth)	Reported Device Performance (ACON® H. pylori Rapid Test Strip)
Compared to Quidel QuickVue One-Step H. pylori gII Test:
Positive Agreement (Target not specified, but similar to predicate)	88% (81%-94% CI)
Negative Agreement (Target not specified, but similar to predicate)	93% (86%-97% CI)
Overall Agreement (Target not specified, but similar to predicate)	90% (86%-94% CI)
Compared to Beckman Coulter FlexSure HP Test:
Positive Agreement (Target not specified, but similar to predicate)	90% (80%-96% CI)
Negative Agreement (Target not specified, but similar to predicate)	98% (92%-100% CI)
Overall Agreement (Target not specified, but similar to predicate)	94% (90%-97% CI)
Compared to Culture/Histology:
Sensitivity (Target not specified, but clinically acceptable)	88% (82%-93% CI)
Specificity (Target not specified, but clinically acceptable)	89% (83%-93% CI)
Accuracy (Target not specified, but clinically acceptable)	88% (84%-92% CI)
Compared to Histology/Rapid Urease Test:
Sensitivity (Target not specified, but clinically acceptable)	70% (58%-81% CI)
Specificity (Target not specified, but clinically acceptable)	86% (77%-92% CI)
Accuracy (Target not specified, but clinically acceptable)	79% (72%-85% CI)

ACON® H. pylori Rapid Test Device:

Acceptance Criteria (Implied by Predicate Devices / Ground Truth)	Reported Device Performance (ACON® H. pylori Rapid Test Device)
Compared to Quidel QuickVue One-Step H. pylori gII Test:
Positive Agreement (Target not specified, but similar to predicate)	88% (81%-94% CI)
Negative Agreement (Target not specified, but similar to predicate)	93% (86%-97% CI)
Overall Agreement (Target not specified, but similar to predicate)	90% (86%-94% CI)
Compared to Beckman Coulter FlexSure HP Test:
Positive Agreement (Target not specified, but similar to predicate)	98% (92%-100% CI)
Negative Agreement (Target not specified, but similar to predicate)	99% (94%-100% CI)
Overall Agreement (Target not specified, but similar to predicate)	99% (96%-100% CI)
Compared to Culture/Histology:
Sensitivity (Target not specified, but clinically acceptable)	89% (82%-94% CI)
Specificity (Target not specified, but clinically acceptable)	89% (83%-93% CI)
Accuracy (Target not specified, but clinically acceptable)	89% (85%-92% CI)
Compared to Histology/Rapid Urease Test:
Sensitivity (Target not specified, but clinically acceptable)	73% (61%-83% CI)
Specificity (Target not specified, but clinically acceptable)	83% (73%-90% CI)
Accuracy (Target not specified, but clinically acceptable)	78% (71%-84% CI)

The study concludes that the ACON H. pylori Rapid Test Strip and Test Device are "substantially equivalent" to the predicate devices and "suitable for professional and point-of-care use", indicating that the reported performance met the acceptance criteria for regulatory clearance. Specific numerical thresholds for acceptance criteria are not explicitly stated beyond achieving substantial equivalence.

2. Sample size used for the test set and the data provenance

A total of 484 clinical specimens were used for the clinical evaluation of accuracy.

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth (Culture/Histology or Histology/Rapid Urease Test).

4. Adjudication method for the test set

The document does not specify the adjudication method used for the test set results. The comparison is made against existing diagnostic methods (predicate devices and ground truth methods), implying that the results from these methods were considered definitive.

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 not applicable. The device is an immunochromatographic rapid test for the detection of antibodies to H. pylori. It is a standalone diagnostic test, not an AI-assisted tool for human readers. Therefore, an MRMC study related to human reading improvement with AI assistance was not performed.

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

Yes, a standalone performance study was done. The ACON® H. pylori Rapid Test Strip and Device are described as "immunoassays" that "can be performed without the use of an instrument" and provide "Colored Lines" as the endpoint. This indicates that the reported performance reflects the device's inherent ability to detect H. pylori antibodies qualitatively, independent of subjective human interpretation beyond visual confirmation of colored lines. The accuracy studies compare the device's results directly against established diagnostic methods.

7. The type of ground truth used

The ground truth used for performance validation was a combination of:

Culture/Histology
Histology/Rapid Urease Test

Additionally, the devices' performance was compared against two predicate devices:

Quidel QuickVue One-Step H. pylori gII Test
Beckman Coulter FlexSure HP

8. The sample size for the training set

The document does not specify the sample size for a training set. As this is a rapid immunochromatographic test, rather than a machine learning algorithm, the concept of a "training set" in the context of AI models is not directly applicable. The device's formulation and design are developed through analytical studies, but this process is distinct from the algorithmic training of AI. The provided data focuses on clinical validation.

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

This is not applicable as there is no explicitly defined "training set" in the context of an AI algorithm described for this device. The ground truth for the clinical evaluation (test set) was established through Culture/Histology and Histology/Rapid Urease Test.

Summary

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7. SUMMARY OF 510(k)

This summary of 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 K024350.

Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121 Tel.: 858-535-2030 Fax: 858-535-2038

Establishment Registration Number: 2531491 Owner/Operator Number: 9033096

Date:

December 27, 2002

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® H. pylori Rapid Test Strip ACON® H. pylori Rapid Test Device

Common Name:

Immunochromatographic test for the qualitative detection of IgG antibodies specific to Helicobacter pylori (H. pylori).

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Classification Information:

The ACON® H. pylori Rapid Test Strip and Device are similar to other FDAcleared devices for the qualitative detection of IgG antibodies specific to H. pylori.

Classification:	Class I
Regulation Number:	866.3110
Product Code:	LYR
Classification Name:	Campylobacter pylori
Complexity:	Moderate
Analyte:	IgG antibodies specific to Helicobacter pylori in humanblood, serum or plasma
Test Category:	Manual procedures with limited steps and limited sampleand reagent preparation

Intended Use:

The ACON® H. pylori Rapid Test Strip and Device are rapid chromatographic immunoassays for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for health professionals and professionals at point-of-care sites.

Description:

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Comparison to Predicate Devices:

A summary of comparison of the features of the ACON® H. pylori Rapid Test Strip, ACON® H. pylori Rapid Test Device, and two predicate devices is shown below:

ACON H. pylori Tests versus Quidel QuickVue One-Step H. pylori gII (K991747)

	ACON® H. pylori RapidTest Strip	ACON® H. pylori Rapid TestDevice	Quidel QuickVue One-Step H. pylori gII
Feature
	Indicationforuse	A rapid chromatographicimmunoassay for thequalitative detection ofantibodies to Helicobacterpylori in whole blood to aid inthe diagnosis of H. pyloriinfection.	A rapid chromatographicimmunoassay for the qualitativedetection of antibodies toHelicobacter pylori in whole bloodto aid in the diagnosis of H. pyloriinfection.
	Intended Use	Professional	Professional
	Intendedspecimen	Whole blood, serum, plasma	Whole blood, serum, plasma
	Endpoint	Colored Lines	Colored Lines
	Materialsprovided	Test stripsDisposable sample test tubesDisposable droppersCapillary tubeDispensing bulbPositive controlNegative controlBufferPackage insertProcedure card	Test devicesDisposable droppersCapillary tubeDispensing bulbPositive controlNegative controlBufferPackage insertProcedure card
	Methodology	Membrane particle assay	Membrane particle assay
	Test Time	10 minutes	10 minutes
	Format	Antigen/antibodyimmunoassay	Antigen/antibody immunoassay

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ACON H. pylori Tests versus Beckman Coulter FlexSure HP (K934863)

	ACON® H. pylori RapidTest Strip	ACON® H. pylori Rapid TestDevice	Beckman CoulterFlexSure HP
Feature
Indication for use	A rapid chromatographicimmunoassay for thequalitative detection ofantibodies to Helicobacterpylori in whole blood to aid inthe diagnosis of H. pyloriinfection.	A rapid chromatographicimmunoassay for the qualitativedetection of antibodies toHelicobacter pylori in whole bloodto aid in the diagnosis of H. pyloriinfection.	A rapid, visually read,qualitativeimmunochromato-graphic method for thedetection of IgGantibodies to H. pylori inserum as an aid in thediagnosis of H. pyloriinfection in patients withclinical signs andsymptoms ofgastrointestinal disease isnot intended for use withasymptomatic patients.
Intended Use	Professional	Professional	Professional
Intendedspecimen	Whole blood, serum, plasma	Whole blood, serum, plasma	Serum
Endpoint	Colored Lines	Colored Lines	Colored Lines
Materialsprovided	Test stripsDisposable sample test tubesDisposable droppersCapillary tubeDispensing bulbPositive controlNegative controlBufferPackage insertProcedure card	Test devicesDisposable droppersCapillary tubeDispensing bulbPositive controlNegative controlBufferPackage insertProcedure card	Test cardsDisposable transferpipettesCapillary tubeBufferProduct Instructions
Methodology	Membrane particle assay	Membrane particle assay	Membrane particle assay
Test Time	10 minutes	10 minutes	4 minutes
Format	Antigen/antibodyimmunoassay	Antigen/antibody immunoassay	Antigen/antibodyimmunoassay

Accuracy

A clinical evaluation was conducted using a total of 484 clinical specimens. The detection of H. pylori specific antibodies was done by using the ACON® H. pylori Rapid Test Strip and Test Device, QuickVue One-Step H. pylori gII Test and Beckman FlexSure HP Test.

ACON® H. pylori Rapid Test Strip compared to Quidel QuickVue One-Step H. pylori gII Test

Positive Agreement = 92/104 = 88% (81%-94%)* Negative Agreement = 89/96 = 93% (86%-97%) Overall Agreement = 181/200 = 90% (86%-94%) * 95% Confidence Intervals

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ACON® H. pylori Rapid Test Strip compared to Beckman Coulter FlexSure HP

Positive Agreement = 61/68 = 90% (80%-96%) Negative Agreement = 93/95 = 98% (92%-100%) Overall Agreement = 154/163 = 94% (90%-97%)

ACON® H. pylori Rapid Test Strip compared to Culture/Histology:

Sensitivity = 120/136 = 88% (82%-93%) Specificity = 164/185 = 89% (83%-93%) Accuracy = 284/321 = 88% (84%-92%)

ACON® H. pylori Rapid Test Strip compared to Histology/Rapid Urease Test:

Sensitivity = 50/71 = 70% (58%-81%) Specificity = 79/92 = 86% (77%-92%) Accuracy = 129/163 = 79% (72%-85%)

ACON H. pylori Rapid Test Device compared to QuickVue One-Step H. pylori gII Test

Positive Agreement = 92/104 = 88% (81%-94%) Negative Agreement = 89/96 = 93% (86%-97%) Overall Agreement = 181/200 = 90% (86%-94%)

ACON H. pylori Rapid Test Device compared to Beckman Coulter FlexSure HP Test

Positive Agreement = 67/68 = 98% (92%-100%) Negative Agreement = 94/95 = 99% (94%-100%) Overall Agreement = 161/163 = 99% (96%-100%)

ACON H. pylori Rapid Test Device compared to Culture/ Histology:

Sensitivity = 121/136 = 89% (82%-94%) Specificity = 164/185 = 89% (83%-93%) Accuracy = 285/321 = 89% (85%-92%)

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ACON H. pylori Rapid Test Device compared to Histology/Rapid Urease Test

Sensitivity = 52/71 = 73% (61%-83%) Specificity = 76/92 = 83% (73%-90%) Accuracy = 128/163 = 78% (71%-84%)

Conclusion:

Clinical and laboratory studies included in this 510(k) submission demonstrate that the ACON H. pylori Rapid Test Strip and Test Device are substantial equivalent to the QuickVue One-Step H. pylori gII Test and the Beckman Coulter FlexSure HP which are already marketed in the U. S. They further demonstrate that these ACON H. pylori rapid test products are suitable for professional and point-of-care use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the bird figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 2 2003

Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121

Re: K024350 Trade/Device Name: ACON® H. pvlori Rapid Test Strip ACON® H. pylori Rapid Test Device Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: December 27, 2002 Received: December 30, 2002

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE 9.

510(k) Number:

Rose 2009 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

ACON® H. pylori Rapid Test Strip Device Name:

ACON® H. pylori Rapid Test Device

The ACON® H. pylori Rapid Test Strip and ACON® H. pylori Rapid Test Indications for Use: Device are rapid chromatographic immunoassays for the qualitative detection of antibodies specific to H. pylori in human whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for healthcare professionals and professionals at point of care sites only.
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ " Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Or (Per 21 CFR 801.109)

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

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).