The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.

Device Description

Visually read, single use test cassette.

AI/ML Overview

The provided 510(k) summary for the AccuStat H. pylori One Step Test does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria. It primarily focuses on establishing substantial equivalence to predicate devices.

However, based on the information provided, here's what can be extracted and inferred regarding performance and study details:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria (e.g., minimum sensitivity, specificity) are stated in the document. The filing focuses on demonstrating substantial equivalence to predicate devices with similar methodology and intended use. Therefore, a table of acceptance criteria and reported performance cannot be directly constructed from this document.

The document mentions that the predicate devices, Smith Kline FlexSure HP and QuickVue One-Step H. Pylori tests, have been determined eligible for a CLIA waiver due to their simple methodologies. This implies that the new device, by being substantially equivalent, would also aim for similar ease of use and performance suitable for such waiver.

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

The 510(k) summary does not provide details on the sample size used for the test set or the provenance (e.g., country of origin, retrospective/prospective) of the data used for performance claims.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The 510(k) summary does not specify the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set. Given the nature of a rapid diagnostic test for antibodies, the result is typically a direct visual interpretation by the user/technician, rather than a process requiring expert adjudication in a clinical trial context as might be seen for imaging devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. This is expected as the device is a manual, visually interpreted immunoassay, not an AI-powered diagnostic tool.

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

The 510(k) summary does not refer to a standalone algorithm performance study. The device is a "visually read, single use test cassette," implying human interpretation is an integral part of its use, and there is no standalone algorithm.

7. The Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used for any performance evaluation. For a serological test detecting antibodies to H. pylori, ground truth would typically be established by:

Culture: Gold standard for direct detection of H. pylori.
Histology: Biopsy examination for H. pylori presence.
Urea Breath Test (UBT) or Stool Antigen Test (SAT): Non-invasive tests for active infection.
Expert Consensus on a combination of clinical symptoms and other diagnostic tests: Especially for establishing H. pylori infection status in symptomatic patients.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information about a training set or its sample size. This type of information is typically relevant for machine learning or AI-driven devices, which is not the case here.

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

Since no training set is mentioned or implied, the method for establishing its ground truth is also not provided.

Summary

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510(k) Summary

MAR - 3 1998
K973523

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter Owner/Operator name, address, Cortecs Diagnostics Limited contact Newtech Square Deeside Industrial Park Deeside, Flintshire CH5 2NT Wales

USA Regulatory Representative/Distributor Boehringer Mannheim Corporation 9115 Hague Rd. Indianapolis. IN 46250 (317) 845-2000

Contact Person: Mike Flis

Date Prepared: September 15, 1997

Device name Proprietary name: AccuStat™ H. pylori One Step Test Common name: Laboratory Test for the Detection of Antibodies to Helicobacter pylori Classification name: Campylobacter fetus serological reagents

The Cortecs Diagnostics Limited AccuStat H. pylori One Step Test is 3) Predicate device substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Cortecs Helisal Rapid Blood Test (510(k) file #K953686). The AccuStat H. pylori One Step Test is also substantially equivalent to Smith Kline FlexSure HP and QuickVue One-Step H. Pylori tests. The latter two tests have been determined by the Center for Disease Control and Prevention (CDC) as being eligible for a CLIA waiver due to the simple methodologies employed.

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510(k) Summary, Continued

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4) Device Description	Visually read, single use test cassette.
5) Intended use	The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori ( H. pylori ) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.

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510(k) Summary, Continued

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Feature	AccuStat H. pyloriOne Step Test(new device)	Cortecs Helisal RapidBlood Test(Primary Predicate)	Smith Kline FlexSureHP Test(Secondary Predicate)	Quidel QuickVueOne-Step H. pyloriTest(Secondary Predicate)
Detects	Human antibody toHelicobacter pylori	Human IgG antibody toHelicobacter pylori	Human IgG antibody toHelicobacter pylori	Human IgG antibody toHelicobacter pylori
Methodology	Immunochromatography(visually interpreted)	Immunochromatography(visually interpreted)	Immunochromatography(visually interpreted)	Immunochromatography(visually interpreted)
Qualitative Test?	Yes	Yes	Yes	Yes
Test Components	Single use test cassette	Single use test card andbuffer	Single use test card andbuffer	Single use test cassette
Minimum testsample	1-2 drops of whole blood orserum (50 µL)	20µL whole blood	80µL whole blood or serum	140 µL whole blood or serum
Procedural Steps	1. Add sample2. Wait3. Read result	1. Fill capillary tube2. Drop tube in buffer3. Mix4. Add sample to test card5. Wait6. Wipe card7. Add reagent8. Wait9. Read result	1. Add buffer2. Add sample3. Wait4. Close test card5. Wait6. Read result	1. Add sample2. Wait3. Read result
Total test time	≤ 5 minutes	5-10 minutes	6-7 minutes	10 minutes
Quality control	Internal procedural control	Internal procedural control	Internal procedural control	Internal procedural control
StorageRecommendation	Room temperature	Room temperature	Refrigerated	Room temperature

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, IN 46250

MAR - 3 1998

Re: K973523 Trade Name: AccuStat H. pylori One Step Test Regulatory Class: I Product Code: LYR Dated: December 15, 1997 Received: December 16, 1997

Dear Mr. Flis:

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, 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 CLA 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 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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Indications for Use Statement

510(k) Number (if known): 1 973523 Device Name: AccuStat H. pylori One Step Test

Indications for Use:

(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

Prescription Use V (Per 21 CFR 801.109)

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

Öst

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).