← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K033064

# MYCOPLASMA IGG (K033064)

_Trinity Biotech USA · LON · Nov 26, 2003 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K033064

## Device Facts

- **Applicant:** Trinity Biotech USA
- **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md)
- **Decision Date:** Nov 26, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Trinity Biotech Captia™ Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as and aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.

## Device Story

The Captia Mycoplasma IgG ELISA is an in vitro diagnostic test for human serum. It utilizes purified Mycoplasma pneumoniae antigen immobilized on 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 concentration. The test is performed in clinical laboratories by trained technicians. Results are used by physicians to aid in the diagnosis of Mycoplasma pneumoniae infection by identifying seroconversion or significant antibody increases in paired acute and convalescent serum samples. The device provides semi-quantitative or qualitative results to assess patient immunological experience.

## Clinical Evidence

No clinical data provided. Device is a distributor name change for a previously cleared predicate (K971393); performance characteristics were established in the predicate submission.

## Technological Characteristics

Enzyme-Linked Immunosorbent Assay (ELISA) using purified Mycoplasma pneumoniae antigen coated on solid-phase microtiter wells. Employs enzyme-labeled anti-human IgG conjugate and substrate for photometric detection. Designed for semi-quantitative or qualitative analysis. Standard laboratory equipment required for photometric measurement.

## Regulatory Identification

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

## Predicate Devices

- Mycoplasma IgG ELISA Test Kit ([K971393](/device/K971393.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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

A. 510(k) Number:
K033064

B. Analyte:
Mycoplasma pneumonia

C. Type of Test:
Enzyme-Linked Immunosorbent Assay

D. Applicant:
Trinity Biotech USA

E. Proprietary and Established Names:
Trinity Biotech Captia Mycoplasma IgG Enzyme-Linked Immunosorbent Assay (ELISA)

F. Regulatory Information:
1. Regulation section:
866.3375
2. Classification:
Class I
3. Product Code:
LJZ
4. Panel:
83

G. Intended Use:
1. Intended use(s):
The Trinity Biotech Captia Mycoplasma IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Trinity Biotech Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
2. Indication(s) for use:
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of

{1}

Page 2 of 4

immunological experience. The IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.

3. Special condition for use statement(s):
Not Applicable

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

H. Device Description:
This is an ELISA kit that contains Mycoplasma (FH strain, grown in PPLO broth, washed, detergent treated, and sonicated) 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):
Mycoplasma IgG ELISA Test Kit
2. Predicate K number(s):
K971393
3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | Detect Mycoplasma IgG antibodies in human serum | Detect Mycoplasma 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 | 1 cutoff calibrator, high, low, and negative controls
Multiply cutoff calibrator  |

{2}

Page 3 of 4

|   | by correction factor | by correction factor  |
| --- | --- | --- |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  None | None | none  |

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

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 indicative of the presence 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 name of distributor only.
Performance characteristics were established in K971393.
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

{3}

Page 4 of 4

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.

M. Conclusion:
The Trinity Biotech Captia Mycoplasma IgG ELISA is substantially equivalent in performance to the predicate device for the determination of immunological experience to Mycoplasma IgG antibodies.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K033064](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K033064)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com