IMMUNOCARD H. PYLORI

K961508 · Meridian Diagnostics, Inc. · LYR · Jan 21, 1997 · Microbiology

Device Facts

• Record ID: K961508
• Device Name: IMMUNOCARD H. PYLORI
• Applicant: Meridian Diagnostics, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Jan 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

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 Story

Membrane-based enzyme immunoassay (EIA) for qualitative detection of IgG to H. pylori. Input: human serum, plasma, or whole blood. Process: sample migrates through wicks to reaction ports; mouse monoclonal anti-human IgG conjugated with alkaline phosphatase added; wash buffer and BCIP substrate added. Output: visual color change (blue) in reaction port. Procedural control port confirms validity. Used in clinical laboratories or physician offices. Results aid clinicians in diagnosing H. pylori infection.

Clinical Evidence

Bench testing only. Performance evaluated against predicate device using 108 samples (serum, plasma, whole blood). Relative agreement 99.1% (95% CI: ± 1.8%). Reproducibility for positive/negative controls and specimens was 100% for both intra-assay and inter-assay testing.

Technological Characteristics

Membrane-based EIA; lateral flow-style migration; alkaline phosphatase-conjugated mouse monoclonal anti-human IgG; BCIP substrate; visual readout; procedural control port (immobilized human IgG).

Indications for Use

Indicated for the qualitative detection of IgG antibodies to Helicobacter pylori in human serum, plasma, and whole blood to aid in the diagnosis of H. pylori infection.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter 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.

Predicate Devices

• ImmunoCard Helicobacter pylori

Submission Summary (Full Text)

{0}

Meridian Diagnostics, Inc. Cincinnati, OH 45244

K961508
Jan. 21, 1997
510(k) Notification
ImmunoCard H. pylori

# APPENDIX A - 510(k) SUMMARY

## A. Identification Information

1. Submitter's Information:

a. Submitter's Name and Address:

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

b. Phone Number: 1-800-543-1980

c. Contact Person: Allen D. Nickol, Ph.D.
Director Scientific and Regulatory Affairs

d. Date Summary Prepared: March 19, 1996

2. Name of Device: ImmunoCard H. pylori
Classification Name: Campylobacter pylori (LYR)

3. Predicate Equivalent Device: ImmunoCard Helicobacter pylori

4. Description of Device: 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:

a. H. pylori Test Cards (30)
b. Enzyme Conjugate (5ml)
c. Wash Buffer (15ml)
d. Substrate Reagent (15ml)
e. Positive Control (2ml)
f. Negative Control (2ml)
g. Whole Blood Sample Diluent (6.5ml)
h. Heparinized Capillary Tubes (30)
i. Transfer Pipets (30)

## 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 monoclonal antibody to human IgG, conjugated with alkaline phosphatase) are added to each of the two reaction ports.

16N

{1}

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 beyond. After three minutes, two drops of conjugate (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 IgG, serves as a procedural control. Failure of the left hand port to develop a blue color indicates an invalid test.

5. Intended Use: 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.

6. Comparison with Predicate Devices: The following 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. pylori Whole Blood | Positive | Negative |
| Positive | 30 | 0 |
| Negative | 1 | 77 |

n = 108
Relative Agreement = 99.1 ± 1.8%* (107/108)
*95% confidence intervals.

165

{2}

Meridian Diagnostics, Inc.
Cincinnati, OH 45244
510(k) Notification
ImmunoCard H. pylori

A. Additional Information/Nonclinical Test Results:

1. Reproducibility:
a. Intra-assay and Inter-assay reproducibility of 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.

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