The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. ImmunoCard H. pylori may be performed by clinical laboratories or in physician's offices.

Device Description

The ImmunoCard H. pylori assay system is a membrane based EIA for detecting IgG to H. pylori in human serum and plasma. Each kit contains the following components: H. pylori Test Cards (30), Enzyme Conjugate (5ml), Wash Buffer (15ml), Substrate Reagent (15ml), Positive Control (2ml), Neqative Control (2ml), Whole Blood Sample Diluent (6.5ml), Heparinized Capillary Tubes (30), Transfer Pipets (30).

AI/ML Overview

Here's an analysis of the provided text regarding the ImmunoCard H. pylori device, outlining acceptance criteria and supporting study details:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Relative Agreement	99.1 + 1.8% (107/108)

Study Details

Sample Size used for the test set and data provenance:
- Sample Size: 108 (n=108)
- Data Provenance: Not explicitly stated regarding country of origin. The study compares a new device to an existing one, which implies the data could be retrospective from past testing or prospective, but this is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" in this context is the performance of a predicate device (ImmunoCard Helicobacter pylori Whole Blood Assay), not an expert interpretation of a diagnostic sample.
Adjudication method for the test set: Not applicable. The study's "ground truth" is a comparison against a predicate device's result. There is no mention of adjudication among multiple readers or experts.
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: Not applicable. This document describes an in vitro diagnostic (IVD) device, not an AI system. Therefore, MRMC studies and human reader improvement with AI are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself provides a standalone result without human interpretation of a complex image or data. The human interaction is limited to performing the assay and observing a color change. The performance metrics presented (relative agreement) reflect this standalone device performance.
The type of ground truth used: The "ground truth" for this study is the result obtained from the predicate device, ImmunoCard Helicobacter pylori Whole Blood Assay. The new device's performance is measured in terms of agreement with this established device.
The sample size for the training set: Not applicable. This diagnostic device is likely based on immunological reactions, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set in the context of this type of diagnostic device.

Summary

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Meridian Diagnostics, Inc. Cincinnati, OH 45244

APPENDIX A - 510(k) SUMMARY

Identification Information A.

Submitter's Information: 1 .
- Submitter's Name and Address: ំ .

Meridian Diagnostics, Inc. 3471 River Hills Drive 45244 Cincinnati, OH

1-800-543-1980 Phone Number: ు .
Contact Person: Allen D. Nickol, Ph.D. ਾ . Director Scientific and Regulatory Affairs
Date Summary Prepared: March 19, 1996 ੋਂ .
Name of Device: ImmunoCard H. pylori 2. Classification Name: Campylobacter pylori (LYR)
Predicate Equivalent Device: ImmunoCard Helicobacter 3. pylori
Description of Device: The ImmunoCard H. pylori assay 4 . system is a membrane based EIA for detecting IgG to H. pylori in human serum and plasma. Each kit contains the following components:
- H. pylori Test Cards (30) a.
- Enzyme Conjugate (5ml) b.
- Wash Buffer (15ml) c.
- Substrate Reagent (15ml) ದೆ .
- Positive Control (2ml) e.
- Neqative Control (2ml) ェ.
- Whole Blood Sample Diluent (6.5ml) টা ব্যাটি টে
- Heparinized Capillary Tubes (30) h .
- Transfer Pipets (30) ..
  Fri

Serum and Plasma Assay

Two drops of serum or plasma are added to each of the two sample ports. The serum migrates into the sample wicks and up towards the reaction ports and beyond. After one minute, two drops of conjugate (mouse antibody to human IgG, conjugated with monoclonal alkaline phosphatase) are added to each of the two reaction ports.

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Meridian Diagnostics, Inc. Cincinnati, OH 45244

510 (k) Notification ImmunoCard H. pylori

Whole Blood Assay

Four drops of Whole Blood Sample Diluent, then two drops of whole blood are added to a specimen cup. Two drops of the diluted whole blood are added to each of the two sample ports. The blood migrates into the sample wicks and up towards the reaction ports and After three minutes, two drops of conjugate bevond. (mouse monoclonal antibody to human IgG, conjugated with alkaline phosphatase) are added to each of the two reaction ports.

Both Assays

After conjugate absorption, two drops of wash buffer are added to the reaction ports, followed by two drops of substrate (BCIP). Reaction ports are observed for the development of any blue color after five minutes. The development of blue color in the right hand port indicates a positive test result for IgG to H. pylori. A lack of blue color in the right hand port indicates a negative result. The left reaction port, containing immobilized human IqG, serves as a procedural control. Failure of the left hand port to develop a blue color indicates an invalid test.

pylori enzyme Intended Use: The ImmunoCard H. 5. immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood. Test results are intended to aid in the diagnosis of H. pylori ImmunoCard H. pylori may be performed by infection. clinical laboratories or in physician's offices.
The following 6。 Comparison with Predicate Devices: comparison of performance supports the Statement of Equivalence between the ImmunoCard H. pylori and ImmunoCard Helicobacter pylori Whole Blood Assay.

	ImmunoCard H. pylori
ImmunoCard H. pyloriWhole Blood	Positive	Negative
Positive	30	0
Negative	1	77

n = 108

Relative Agreement = = 99.1 + 1.8% (107/108)

"95% confidence intervals.

165

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Meridian Diagnostics, Inc. Cincinnati, OH 45244

510 (k) Notification ImmunoCard H. pylori

Additional Information/Nonclinical Test Results: A.

1. Reproducibility :
- Intra-assay and Inter-assay reproducibility of a. the positive control, negative control, positive specimens and negative specimens was 100%.

2. Sample Storage:

IgG to H. pylori is stable in whole blood for at least three days when stored at 4°C.

166

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).