Mycoplasma Igg
by Trinity Biotech USA 510(k)
Active
510(k) K033064
Overview
The Mycoplasma IgG ELISA Kit is an Enzyme-Linked Immunosorbent Assay (ELISA) designed for the semi-quantitative or qualitative detection of IgG antibodies against Mycoplasma pneumoniae in human serum. This device aids in assessing immunological exposure to the pathogen, supporting diagnostic evaluation in microbiology.
This kit is supplied as a reusable diagnostic reagent system for laboratory use, requiring no sterilisation beyond standard aseptic handling. It is classified under FDA’s Device Class II (regulation number 866.1645) and was cleared via a Traditional 510(k) pathway (K033064). No MRI safety or single-use specifications are noted; storage and handling follow standard ELISA protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033064 | Date26 Nov 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LON
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
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Questions
What is the Mycoplasma IgG ELISA Kit used for in a clinical setting?
The Mycoplasma IgG ELISA Kit is designed for the semi-quantitative or qualitative detection of IgG antibodies against *Mycoplasma pneumoniae* in human serum. It helps clinicians assess whether a patient has been exposed to this pathogen, aiding in the diagnostic evaluation of respiratory or microbiological concerns.
Is this device single-use or reusable, and what are the handling requirements?
This is a reusable diagnostic reagent system intended for laboratory use. It does not require sterilization beyond standard aseptic handling, meaning it can be used multiple times in a controlled lab environment following proper cleaning and maintenance protocols.
How was this device cleared by the FDA, and what regulatory pathway was followed?
The Mycoplasma IgG ELISA Kit was cleared via the Traditional 510(k) pathway under FDA’s Device Class II (regulation number 866.1645). It was determined to be substantially equivalent to a predicate device, as indicated by the clearance type and advisory committee classification for microbiology.
What type of storage and handling instructions should be followed for this kit?
The kit follows standard ELISA protocols for storage and handling, which typically include keeping it in a clean, dry environment away from direct sunlight, extreme temperatures, and contaminants. Specific instructions would align with general laboratory practices for ELISA reagents.