Macra LP(A) Enzyme Immunoassay Kit
by Trinity Biotech USA 510(k)
Active
510(k) K992665
Overview
The Macra LP(A) Enzyme Immunoassay Kit is an in vitro diagnostic device classified as a Lipoprotein, Low-Density, Antigen, Antiserum, Control combination. It employs enzyme-linked immunosorbent assay (ELISA) technology to quantitatively measure Lipoprotein(a) concentrations in human serum or plasma, aiding in cardiovascular risk assessment.
This kit is intended for use in clinical laboratory settings by trained personnel. Supplied as a single-use diagnostic reagent, it requires no special sterility beyond standard laboratory protocols. The device holds FDA 510(k) clearance (K992665) under the Immunology advisory committee and falls under Device Class II (DFC) regulatory classification. Storage and handling follow standard in vitro diagnostic procedures as outlined in the accompanying instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992665 | Date26 Nov 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DFC
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5600
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Trinity Biotech USA
Questions
What is the primary clinical purpose of the Macra LP(A) Enzyme Immunoassay Kit, and how does it function?
The Macra LP(A) Enzyme Immunoassay Kit is designed to quantitatively measure Lipoprotein(a) concentrations in human serum or plasma using enzyme-linked immunosorbent assay (ELISA) technology. This aids clinicians in assessing cardiovascular risk, as elevated Lipoprotein(a) levels are associated with increased risk of atherosclerotic cardiovascular disease.
Is this kit intended for single-use or repeated use, and what sterility precautions should be taken?
The Macra LP(A) Enzyme Immunoassay Kit is supplied as a single-use diagnostic reagent. Standard laboratory sterility protocols apply, as no special sterility measures beyond typical in vitro diagnostic handling are required. This ensures safe and accurate use in clinical laboratory settings.
Where is this device manufactured, and how should it be stored according to the provided guidelines?
The kit is manufactured by Trinity Biotech USA, located in Jamestown, New York. Storage and handling follow standard in vitro diagnostic procedures as outlined in the accompanying instructions, which should be consulted for specific temperature and stability requirements.
What regulatory pathway was followed for FDA clearance, and what classification does this device hold?
The Macra LP(A) Enzyme Immunoassay Kit received FDA clearance through a traditional 510(k) review process, specifically under the Immunology advisory committee. It is classified as a Device Class II (DFC) under the regulatory framework, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.
Can this kit be used outside of a clinical laboratory setting, or is it restricted to trained personnel?
The kit is explicitly intended for use in clinical laboratory settings by trained personnel. This ensures proper handling, interpretation of results, and adherence to regulatory guidelines, as outlined in the device description.