LEGIONELLA PNEUMOPHILA IGG/IGM

K033051 · Trinity Biotech USA · MJH · Nov 26, 2003 · Microbiology

Device Facts

• Record ID: K033051
• Device Name: LEGIONELLA PNEUMOPHILA IGG/IGM
• Applicant: Trinity Biotech USA
• Product Code: MJH · Microbiology
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3300
• Device Class: Class 2

Indications for Use

The Trinity Biotech Legionella pneumophila IgG/IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila (Legionella) serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The assay is not intended to differentiate between the serotypes of Legionella.

Device Story

The Legionella pneumophila IgG/IgM ELISA is an in vitro diagnostic test used in clinical laboratories. It utilizes purified Legionella pneumophila antigens (serogroups 1-6) immobilized on microtiter wells. Patient serum is added; if specific IgG/IgM antibodies are present, they bind to the antigen. After washing, an enzyme-labeled anti-human IgG/IgM conjugate is added, followed by a substrate solution. The resulting color change is measured photometrically. This indirect measurement of antibody concentration assists clinicians in diagnosing Legionella infection. The device is intended for professional use in a clinical laboratory setting.

Clinical Evidence

Performance evaluated via comparison to Legionella IFA at two sites. Site 1 (n=33): 90.0% positive agreement. Site 2 (n=72): 98.53% positive agreement, 98.57% negative agreement. CDC panel (n=31 serum pairs): 93.5% agreement in detecting seroconversions. Precision studies (intra- and inter-assay) conducted per NCCLS EP5 guidelines, showing acceptable CVs across multiple sites and days.

Technological Characteristics

Enzyme-Linked Immunosorbent Assay (ELISA) using purified Legionella pneumophila antigen (serogroups 1-6) coated on solid-phase microtiter wells. Employs enzyme-labeled anti-human IgG/IgM conjugate and substrate for photometric detection. Quantitative output derived from color intensity measurement.

Indications for Use

Indicated for qualitative detection of total IgG/IgM antibodies to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella disease.

Regulatory Classification

Identification

Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• Wampole Legionella (K963318)

Submission Summary (Full Text)

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

A. 510(k) Number:
K033051

B. Analyte:
Legionella IgG/IgM antibodies

C. Type of Test:
(ELISA) Enzyme Linked Immunosorbent Assay

D. Applicant:
Trinity Biotech USA

E. Proprietary and Established Names:
Trinity Biotech Captia™ Legionella pneumophila IgG/IgM ELISA Test System

F. Regulatory Information:
1. Regulation section:
21 CFR Part 866.3300 Haemophilus spp. Serological reagents
2. Classification:
Class II
3. Product Code:
MJH – Legionella spp. ELISA
4. Panel:
83

G. Intended Use:
1. Intended use(s):
The Trinity Biotech Legionella pneumophila IgG/IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila (Legionella) serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.
2. Indication(s) for use:
The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The assay is not intended to differentiate between the serotypes of Legionella.
3. Special condition for use statement(s):
Not applicable
4. Special instrument Requirements:
Single or dual wavelength microplate reader with a 450 nm filter.

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H. Device Description:

Each kit contains 96 test devices, consisting of Legionella antigen to serogroups 1-6. Purified Legionella pneumophila 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/IgM 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.

I. Substantial Equivalence Information:

1. Predicate device name(s): Wampole Legionella
2. Predicate K number(s): K 963318
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila (Legionella) serogroups 1-6 in serum from patients with clinical suspicion of Legionella disease. | Qualitative determination of IgG and IgM antibodies in human serum to Legionella in patients with clinical signs and symptoms of Legionella disease. |
| Reagents | Horseradish-peroxidase (HRP) conjugate
Goat anti-human IgG/IgM
Sample diluent
Tetramethylbenzidine (TMB) substrate
Wash buffer
Stop solution (H2SO4) | Horseradish-peroxidase (HRP) conjugate
Goat anti-human IgG/IgM
Sample diluent
Tetramethylbenzidine (TMB) substrate
Wash buffer
Stop solution (H2SO4) |
| Technology | ELISA | ELISA |
| Calibrators | High and Low positive, negative | High and Low positive, negative |
| Differences | | |
| Item | Device | Predicate |
| None | None | None |

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

K. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable. Performance characteristics and substantial equivalence were previously established in the Wampole predicate device (K963318). The submission was submitted for a name and address change.
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

L. Conclusion:
The Trinity Biotech Captia™ Legionella pneumophila IgG/IgM ELISA Test System is substantially equivalent in performance to the predicate device.