CHLAMYDIA IGG ELISA TEST SYSTEM

K033079 · Trinity Biotech USA · LJC · Nov 26, 2003 · Microbiology

Device Facts

• Record ID: K033079
• Device Name: CHLAMYDIA IGG ELISA TEST SYSTEM
• Applicant: Trinity Biotech USA
• Product Code: LJC · Microbiology
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Indications for Use

The Trinity Biotech Captia™ Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.

Device Story

The Captia Chlamydia IgG ELISA is an in vitro diagnostic test used in clinical laboratories to detect IgG antibodies to Chlamydia in human serum. The device utilizes purified Chlamydia antigen (strain LGV II) immobilized on microtiter wells. Patient serum is added; if specific IgG antibodies are present, they bind to the antigen. After washing, an enzyme-labeled anti-human IgG conjugate is added, followed by a substrate solution. The resulting color intensity, measured photometrically, provides an indirect quantitative measurement of specific antibody levels. The output is used by healthcare providers to assess a patient's immunological experience with Chlamydia. The device does not correlate results with active disease presence or absence.

Clinical Evidence

No clinical data provided. Performance characteristics were established in the predicate device submission (K962558).

Technological Characteristics

Enzyme-Linked Immunosorbent Assay (ELISA) using purified Chlamydia antigen (strain LGV II) on solid-phase microtiter wells. Employs enzyme-labeled anti-human IgG conjugate and photometric detection. Standalone laboratory test. No software or electronic algorithm described.

Indications for Use

Indicated for the qualitative detection of IgG antibodies to Chlamydia in human serum to determine immunological experience. No specific patient population, age, or gender restrictions are provided; not indicated for diagnosing active chlamydia infection.

Regulatory Classification

Identification

Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
K033079

B. Analyte:
Chlamydia

C. Type of Test:
Enzyme-Linked Immunosorbent Assay

D. Applicant:
Trinity Biotech USA

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

F. Regulatory Information:
1. Regulation section:
866.3120
2. Classification:
Class I
3. Product Code:
LJC
4. Panel:
83

G. Intended Use:
1. Intended use(s):
The Trinity Biotech Captia Chlamydia IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.
2. Indication(s) for use:
The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.
3. Special condition for use statement(s):
Not Applicable
4. Special instrument Requirements:
Single or dual wavelength microplate reader with 450 nm filter

{1}

Page 2 of 4

H. Device Description:
This is an ELISA kit that contains Chlamydia (strain LGV II, mainly reticulate from, grown in cell culture, harvested by freeze thawing, cushion clarified, and solubilized with detergent) 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.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Wampole Chlamydia IgG ELISA Test System
2. Predicate K number(s):
K962558
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Detect Chlamydia IgG antibodies in human serum | Detect Chlamydia 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

{2}

Page 3 of 4

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 distributor only. Performance characteristics were established in K962558.
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

{3}

Page 4 of 4

**M. Conclusion:**

The Trinity Biotech Captia Chlamydia IgG ELISA is substantially equivalent in performance to the predicate for the identification of Chlamydia in human serum.