Human Beta-2 Microglobin En-Rid Kit
by The Binding Site, Ltd. 510(k)
Active
510(k) K913131
Overview
The Human Beta-2 Microglobulin En-RID Kit is an immunological test system designed for the qualitative detection of beta-2 microglobulin in human serum or plasma. Beta-2 microglobulin is a low-molecular-weight protein associated with the major histocompatibility complex (MHC) class I molecules, and its measurement is clinically relevant in monitoring conditions such as renal impairment, multiple myeloma, and other hematological disorders.
This kit is intended for in vitro diagnostic use in clinical laboratories. Supplied as a single-use reagent system, it requires no special storage conditions beyond refrigeration and protection from light. The device is classified under FDA regulation 866.5630 as a Class II medical device and holds a 510(k) clearance (K913131) with a product code of JZG. It is intended for use in immunology testing environments and adheres to standard laboratory safety protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913131 | Date7 Nov 1991 | 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- Withdrawn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 The Binding Site, Ltd.
Questions
What clinical conditions is this kit primarily used to monitor, and why is beta-2 microglobulin relevant in those cases?
This kit detects beta-2 microglobulin, a protein linked to the major histocompatibility complex (MHC) class I molecules, which is clinically useful for monitoring renal impairment and hematological disorders like multiple myeloma. Elevated levels of beta-2 microglobulin can indicate impaired kidney function or disease progression in conditions such as myeloma, making it a valuable biomarker for these conditions.
Is this kit single-use, and if so, what storage requirements apply to maintain its integrity?
Yes, the Human Beta-2 Microglobulin En-RID Kit is designed for single-use only. To preserve its stability, it should be stored under refrigeration and protected from light, as no additional specialized storage conditions are required.
What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical laboratories?
The kit received FDA clearance through a 510(k) submission (K913131) under the Traditional pathway, classified as a Class II device (product code JZG) for immunological testing. This clearance confirms its compliance with FDA standards for in vitro diagnostic use in clinical laboratories, ensuring it adheres to safety and performance requirements for monitoring conditions like renal impairment and multiple myeloma.
Are there multiple kit sizes or models available, or is this a standardized single-format test system?
The provided data does not specify multiple sizes or models for the Human Beta-2 Microglobulin En-RID Kit. It is described as a single-use reagent system with no mention of variations, implying a standardized format for qualitative detection of beta-2 microglobulin in human serum or plasma.