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

Indications for 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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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033067

B. Analyte:
Helicobacter pylori

C. Type of Test:
Enzyme-Linked Immunosorbent Assay

D. Applicant:
Trinity Biotech USA

E. Proprietary and Established Names:
Trinity Biotech Captia H. pylori IgG Enzyme-Linked Immunosorbent Assay

F. Regulatory Information:
1. Regulation section:
866.3110
2. Classification:
Class I
3. Product Code:
LYR
4. Panel:
83

G. Intended Use:
1. Intended use(s):
The Trinity Biotech Captia H. pylori IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgG antibodies to Helicobacter pylori in human serum. This assay is intended for use as an aid in the diagnosis of H. pylori infection in persons with gastrointestinal symptoms.
2. Indication(s) for use:
The 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.
3. Special condition for use statement(s):
Not Applicable

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4. Special instrument Requirements:
Single or dual wavelength microplate reader with 450 nm filter

H. Device Description:
This is an ELISA kit that contains H. pylori (strain ATCC 43504) antigen coated microassay plate in a 96 well configuration, serum diluent, cutoff calibrator, a high positive, low positive, and negative control, horseradish-peroxidase conjugate, Chromogen/substrate solution, wash buffer and stop solution. It can be purchased with enough supplies for one or five plates.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Pylori IG ELISA Test System
2. Predicate K number(s):
K961221
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Detect H. pylori IgG antibodies in human serum | Detect H. pylori IgG antibodies in human serum |
| Reagents | Tris BSA Serum Diluent Tris Tween Wash Buffer Goat anti-human IgG (Fc) | Tris BSA Serum Diluent Tris Tween Wash Buffer Goat anti-human IgG (Fc) |
| Technology | ELISA | ELISA |
| Reagents | Horseradish Peroxidase Conjugate TMB enzyme substrate Sulfuric Acid Stop | Horseradish Peroxidase Conjugate TMB enzyme substrate Sulfuric Acid Stop |
| Procedure | Serum incubation-20 min Conjugate incubation-20min Substrate incubation-10min Stop-add 100μl of stop solution Read at 450nm | Serum incubation-20 min Conjugate incubation-20min Substrate incubation-10min Stop-add 100μl of stop solution Read at 450nm |
| Calculations | 1 cutoff calibrator, high, low, and negative controls Multiply cutoff calibrator by correction factor | 1 cutoff calibrator, high, low, and negative controls Multiply cutoff calibrator by correction factor |
| Differences | | |
| Item | Device | Predicate |
| None | None | None |

J. Standard/Guidance Document Referenced (if applicable):
Not Applicable

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K. Test Principle:

Enzyme-Linked Immunosorbent Assays (ELISA) rely on the ability of biological materials, (i.e. antigens) to adsorb to plastic surfaces such as polystyrene (solid phase). When antigens bound to the solid phase are brought into contact with a patient's serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antigen-antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgG conjugated with horseradish peroxidase which then binds to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate Tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient's serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4, the contents of the wells turn yellow. The color, which is proportional to the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable. This is a change in the name of distributor only. Performance characteristics were established in K961221.
b. Linearity/assay reportable range:
Not Applicable
c. Traceability (controls, calibrators, or method):
Not Applicable
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a and b are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

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**M. Conclusion:**

The Trinity Biotech Captia *H. pylori* IgG ELISA is substantially equivalent in performance to the predicate device and to biopsy for the identification of H. pylori in human serum.