Human IgG Subclass Kit Use With The Beckman Image Analyzer
by The Binding Site, Ltd. 510(k)
Active
510(k) K000701
Overview
The Human IgG Subclass Kit is an in vitro diagnostic reagent set designed for use on the Beckman Immage Analyzer. It enables the quantitative measurement of IgG subclasses 1, 2, 3, and 4 in human serum samples.
This device is supplied as a kit for laboratory use and is intended for quantitative measurement applications. It is a Class II device cleared by the FDA under 510(k) K000701 with product code CFN. The device is not described as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000701 | Date27 Apr 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CFN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from The Binding Site, Ltd.
Questions
What immunoglobulin subclasses does this kit measure?
The kit provides quantitative measurement of the four human IgG subclasses—IgG1, IgG2, IgG3, and IgG4—allowing laboratories to assess subclass distribution in serum samples.
Is the kit intended for single‑use or can it be reused?
The product description does not specify single‑use or reusable status. Because it is supplied as a reagent kit for laboratory use, each assay is typically performed with fresh reagents, but the kit’s components may be used for multiple runs according to the manufacturer’s protocol.
What equipment is required to run this assay?
The assay is designed specifically for the Beckman Image Analyzer. The analyzer performs the nephelometric detection needed for the quantitative IgG subclass measurements, so compatibility with that instrument is essential.
How is the kit regulated and what clearance does it have?
The Human IgG Subclass Kit is a Class II in‑vitro diagnostic device cleared by the FDA under 510(k) number K000701, with product code CFN. This indicates it was found substantially equivalent to a legally marketed predicate device.