PYLORI IGG

K033067 · Trinity Biotech USA · LYR · Nov 26, 2003 · Microbiology

Device Facts

• Record ID: K033067
• Device Name: PYLORI IGG
• Applicant: Trinity Biotech USA
• Product Code: LYR · Microbiology
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The Trinity Biotech Captia™ H. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori, as an aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease, and is not intended for use in asymptomatic patients.

Device Story

The Captia H. pylori IgG ELISA is an in vitro diagnostic test for qualitative detection of IgG antibodies to H. pylori in human serum. The device uses purified H. pylori antigen attached to microtiter wells. Patient serum is added; if specific IgG antibodies are present, they bind to the antigen. After washing, enzyme-labeled anti-human IgG is added, followed by a substrate solution. The resulting color change is measured photometrically, providing an indirect measurement of antibody levels. The test is performed in a clinical laboratory setting by trained personnel. Results assist clinicians in diagnosing H. pylori infection in symptomatic patients, supporting clinical decision-making regarding treatment. The device benefits patients by providing a non-invasive serological method to identify H. pylori infection.

Clinical Evidence

No clinical data provided. Device is a distributor name change; performance characteristics established in predicate K961221.

Technological Characteristics

Enzyme-Linked Immunosorbent Assay (ELISA) utilizing purified H. pylori antigen coated on solid-phase microtiter wells. Detection via enzyme-labeled anti-human IgG conjugate and substrate-induced colorimetric reaction measured photometrically. In vitro diagnostic use.

Indications for Use

Indicated for qualitative determination of IgG antibodies to Helicobacter pylori in human serum as an aid in diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease; not intended for asymptomatic patients.

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

• Pylori IG ELISA Test System (K961221)

Submission Summary (Full Text)

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NOV 26 2003

K033067

Summary of Safety and Effectiveness Information H. pylori IgG ELISA Test Kit

I. Trinity Biotech 2823 Girts Road Jamestown, NY 14701 Contact person: Bonnie B. DeJoy Telephone: [phone] Date of preparation: Nov. 20, 2003

II. Description of Device

The H. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to antigen. The Trinity Pylori IgG ELISA assay may be used as an aid in the diagnosis of Helicobacter pylori infection in persons with gastrointestinal symptoms. For In Vitro Diagnostic Use Only.

The H. pylori IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Helicobacter pylori. Purified Helicobacter pylori antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

III. Predicate Device

The H. pylori IgG ELISA test is substantially equivalent to biopsy. Equivalence is demonstrated by the following comparative results:

### Performance Characteristics

#### A. Evaluation of Pylori IgG ELISA Sensitivity and Specificity Relative to Biopsy

The Trinity Biotech H. pylori IgG ELISA is a modification of Pylori Stat. Pylori Stat was originally evaluated by masked testing 386 serum from five geographically different areas. having biopsy with stain or culture results for H. pylori. The serum were from patients with random gender and various ages with the following clinical diagnoses: gastric ulcer, duodenal ulcer, non-ulcer dyspepsia, esophagitis and normal. Table 1 illustrates the sensitivity and specificity of the Pylori Stat to biopsy.

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# Table 1 Pylori Stat IgG ELISA Sensitivity and Specificity

| | | Pylori Stat | | | |
|-----------------------------------------------------------------------------------------------|-------|-------------|-----------------------------------------------------------------------------------------------------------------------------|-----|-------|
| | | + | eq | - | Total |
| biopsy* | + | 261 | 12 | 4 | 277 |
| | - | 2 | 2 | 105 | 109 |
| | Total | 263 | 14 | 109 | 386 |
| Sensitivity = 261/265 = 98.5%<br>Specificity = 105/107 = 98.1%<br>Agreement = 366/372 = 98.4% | | | 95% Confidence interval = 97.0% - 100%<br>95% Confidence interval = 95.5% - 100%<br>95% Confidence interval = 97.1% - 99.7% | | |

### * Culture or stain

Equivocals were not included in the above calculations.

The 95% confidence intervals were calculated using the normal method.

The Trinity Biotech H. pylori IgG ELISA was evaluated by masked testing 371 serum from five geographically different areas, having biopsy with stain or culture results for H pvlori. The serum were from patients with random gender and various ages with the following clinical diagnoses: gastric ulcer, duodenal ulcer, non-ulcer dyspepsia, esophagitis and normal. Tables 2 and 3 illustrate the sensitivity and specificity of the Trinity Biotech H. pvlori IgG ELISA to biopsy and the % agreement positive and % agreement negative of the Trinity Biotech H. pylori IgG ELISA to Biowhittaker Pylori Stat.

# Table 2 Trinity Biotech H. pylori IgG ELISA Sensitivity and Specificity

### Trinity Biotech H. pylori IgG ELISA

| | + | eq | - | Total |
|-----------------------------------------------------------------------------------------------------|-----|-----------------------------------------------------------------------------------------------------------------------|-----|-------|
| + | 244 | 13 | 9 | 266 |
| biopsy* | 4 | 2 | 99 | 105 |
| Total | 248 | 15 | 108 | 371 |
| Sensitivity = 244/253 = 96.4%95%<br>Specificity = 99/103 = 96.1% 95%<br>Agreement = 343/356 = 96.4% | | Confidence Interval = 94.1% - 98.8%<br>Confidence Interval = 92.3% - 99.9%<br>95% Confidence Interval = 94.4% - 98.3% | | |

* Culture or stain

Equivocals were not included in the above calculations.

The 95% Confidence Intervals were calculated using the normal method.

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# Evaluation of Pylori IgG ELISA % Agreement Positive and % Agreement Negative Relative to Biowhittaker Pylori Stat

| Table<br>3 |
|------------|
|------------|

Trinity Biotech H. pylori IgG ELISA

| | | + | ed | | Total |
|-----------------------------|-------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------|
| | + | 246 | 8 | 2 | 256 |
| | eq | | | 6 | 12 |
| Biowhittaker<br>Pylori Stat | | ನ | ನ | 97 | 103 |
| | Total | 250 | 16 | 102 | 371 |
| 01 1 | : | A 1 C 10 10 00 / | Comment Comments of Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comment | | 10001 |

| % Agreement positive = 246/248 = 99.2% | 95% Confidence Interval = 98.1% - 100% |
|----------------------------------------|-----------------------------------------|
| % Agreement negative = 97/100 = 97.0% | 95% Confidence Interval = 93.6% - 100% |
| % Agreement = 343/348 = 98.6% | 95% Confidence Interval = 97.3% - 99.8% |

Equivocals were not included in the above calculations. The 95% Confidence Intervals were calculated using the normal method.

### B. Precision

The precision of the Trinity Biotech H. pylori IgG ELISA was determined by testing six different sera ten times each on three days. The mean coefficients of variation from the intra- and inter- assays are presented in Table 6.

| Table 4 |
|-------------------------------------------------------------|
| <b>Trinity Biotech <i>H. pylori</i> IgG ELISA Precision</b> |

| Assay 1 (n=10) | | | Assay 2 (n=10) | | | Assay 3 (n=10) | | | Inter-Assay (n=30) | | |
|----------------|-------|-------|----------------|-------|-------|----------------|-------|-------|--------------------|-------|-------|
| X | SD | CV | X | SD | CV | X | SD | CV | X | SD | CV |
| 3.13 | 0.209 | 6.68% | 3.05 | 0.145 | 4.75% | 3.13 | 0.210 | 6.71% | 3.10 | 0.188 | 6.06% |
| 2.08 | 0.151 | 7.26% | 2.15 | 0.156 | 7.26% | 2.01 | 0.127 | 6.32% | 2.08 | 0.151 | 7.26% |
| 2.31 | 0.258 | 11.2% | 2.29 | 0.115 | 5.02% | 2.24 | 0.173 | 7.72% | 2.28 | 0.187 | 8.20% |
| 1.17 | 0.184 | 15.7% | 1.47 | 0.148 | 10.1% | 1.30 | 0.179 | 13.8% | 1.31 | 0.207 | 15.8% |
| 0.06 | 0.018 | 30.0% | 0.12 | 0.014 | 11.7% | 0.11 | 0.056 | 50.9% | 0.08 | 0.031 | 38.8% |
| 0.10 | 0.016 | 16.0% | 0.14 | 0.020 | 14.3% | 0.10 | 0.067 | 67.0% | 0.12 | 0.023 | 19.2% |

### C. Cross Reactivity

The Trinity Biotech H. pylori IgG ELISA ISR values were determined for paired sera from C. jejuni infections and single sera from C. fetus infections. The data in Table 7 shows no rise in antibody for C. jejuni paired sera, and negative responses for C. fetus infections indicating a lack of cross reactivity to these closely related organisms. Serum pairs 1, 2 and 3 demonstrate antibody to H. pylori. However, the pairs do not show a rise in antibody as would be expected in acute C. jejuni infection. Therefore, the response is considered to be specific for H. pylori with no cross reaction with C. jejuni. Sera positive

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for Borrelia burgdorferi by ELISA and Western Blot were negative indicating a lack of cross-reactivity.

| Serum # | Diagnosis* | H. pylori IgG ISR |
|----------------|-----------------------|-------------------|
| Acute 1 | C. jejuni Diarrhea | 2.30 |
| Convalescent 1 | | 2.41 |
| Acute 2 | C. jejuni Diarrhea | 2.11 |
| Convalescent 2 | | 2.23 |
| Acute 3 | C. jejuni Diarrhea | 1.23 |
| Convalescent 3 | | 1.20 |
| Acute 4 | C. jejuni Diarrhea | 0.40 |
| Convalescent 4 | | 0.57 |
| Acute 5 | C. jejuni Diarrhea | 0.88 |
| Convalescent 5 | | 0.89 |
| 6. | C. fetus Endocarditis | 0.59 |
| 7. | C. fetus Endocarditis | 0.63 |
| 8. | C. fetus Endocarditis | 0.72 |
| 9. | C. fetus Bacteremia | 0.38 |

Table 5 Trinity Biotech H. nylori IgG ELISA Results with

*All cases diagnosed by culture; C. jejuni infection by fecal culture on Camplylobacterspecific media, C. fetus infection by blood culture.

| 10. | Borrelia burgdorferi | 0.44 |
|-----|----------------------|------|
| 11. | Borrelia burgdorferi | 0.20 |
| 12. | Borrelia burgdorferi | 0.22 |
| 13. | Borrelia burgdorferi | 0.89 |
| 14. | Borrelia burgdorferi | 0.11 |
| 15. | Borrelia burgdorferi | 0.20 |
| 16. | Borrelia burgdorferi | 0.16 |
| 17. | Borrelia burgdorferi | 0.59 |
| 18. | Borrelia burgdorferi | 0.09 |
| 19. | Borrelia burgdorferi | 0.13 |

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All Borrelia burgdorferi sera were positive for antibodies by ELISA and Western Blot.
Their clinical histories were suggestive of Lyme Disease.

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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 stylized caduceus symbol, which features a staff with a serpent entwined around it, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 26 2003

Ms. Bonnie B. DeJoy Director, Quality Systems Trinity Biotech USA P.O. Box 1059 Jamestown, NY 14702-1059

> k033067 Trade/Device Name: Captia H. Pylori IgG ELISA Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR Dated: September 17, 2003 Received: September 29, 2003

Dear Ms. DeJoy:

Re:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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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#### Page 1 of 1

510(k) Number: K033067

Device Name: Trinity Biotech Captia™ H. pylori IgG ELISA

The Trinity Biotech Captia™ H. pylori IgG ELISA kit is an Indications For Use: Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori, as an aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease, and is not intended for use in asymptomatic patients.

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 XFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

Division Sign-Off
for FMP

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) Ro33067