Tinaquant B 2-MICROGLOBULIN Assay
by Boehringer Mannheim Corp. 510(k)
Active
510(k) K980724
Overview
The Tinaquant B 2-Microglobulin Assay is an immunological test system designed for the quantitative measurement of beta-2-microglobulin in human serum or plasma. Beta-2-microglobulin is a low-molecular-weight protein associated with immune function and used as a biomarker for monitoring conditions such as multiple myeloma, renal function, and inflammatory diseases. This assay employs a sandwich immunoassay principle to detect and quantify the target analyte with high precision.
The device is intended for in vitro diagnostic use in clinical laboratories and is supplied as a reagent kit for automated immunoassay analyzers. It is classified as a Class II medical device under FDA regulations (product code JZG) and has received FDA 510(k) clearance (K980724) as substantially equivalent to predicate devices. The assay requires single-use reagents and is not intended for MRI use or reusable components. Storage and handling follow standard in vitro diagnostic protocols as specified in the accompanying instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980724 | Date16 Oct 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5630
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Boehringer Mannheim Corp.
Questions
What is the Tinaquant B 2-Microglobulin Assay used for?
The Tinaquant B 2-Microglobulin Assay is designed for the quantitative measurement of beta-2-microglobulin in human serum or plasma. Beta-2-microglobulin serves as a biomarker for monitoring conditions such as multiple myeloma, renal function, and inflammatory diseases. The assay employs a sandwich immunoassay technique to detect and measure the protein with high precision, helping clinicians assess disease progression or response to treatment.
How is the Tinaquant B 2-Microglobulin Assay supplied and intended for use?
This assay is supplied as a reagent kit specifically for automated immunoassay analyzers. It is intended exclusively for in vitro diagnostic use in clinical laboratories. The reagents are single-use only and not designed for reuse or MRI compatibility. The kit adheres to standard in vitro diagnostic protocols for storage and handling, as outlined in the accompanying instructions.
Is the Tinaquant B 2-Microglobulin Assay sterile and reusable?
The Tinaquant B 2-Microglobulin Assay is supplied as a single-use reagent kit, meaning each component is intended for one-time use only. Sterility is maintained as part of the kit’s design for in vitro diagnostic applications, ensuring safe and accurate testing. Reusable components are not part of this assay’s construction or intended use.
What regulatory pathway does the Tinaquant B 2-Microglobulin Assay follow?
The Tinaquant B 2-Microglobulin Assay has received FDA 510(k) clearance (K980724) under the Traditional pathway, demonstrating substantial equivalence to predicate devices. It is classified as a Class II medical device under FDA regulations (product code JZG) and falls under the Immunology specialty category. This clearance confirms its compliance with U.S. regulatory standards for in vitro diagnostic use.
How should the Tinaquant B 2-Microglobulin Assay be stored?
Storage instructions are detailed in the accompanying instructions for use, which follow standard in vitro diagnostic protocols. Generally, the reagent kit should be stored according to the manufacturer’s guidelines, which typically include protection from extreme temperatures, light exposure, and contamination. Adhering to these protocols ensures the assay’s accuracy and reliability for quantitative measurements.