Human IgA Liquid Reagent Kit for Use on SPAPLUS
by The Binding Site, Ltd. 510(k)
Active
510(k) K081827
Overview
The Human IgA Liquid Reagent Kit is an in vitro diagnostic assay designed for use on the Binding Site SPAPLUS turbidimetric analyzer. It utilizes turbidimetric technology to measure human IgA concentrations in serum, lithium heparin, or EDTA plasma samples. The device uses monospecific goat anti-IgA antibodies to react with IgA in patient serum or plasma samples, forming insoluble complexes.
This device is supplied as a liquid reagent kit for use on the SPAPLUS turbidimetric analyzer. It is intended for in vitro diagnostic use and is regulated as a Class II device. The device is authorized under FDA 510(k) K081827 with the product code CFN and is manufactured by The Binding Site, Ltd.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081827 | Date19 Dec 2008 | 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- Withdrawn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 is the purpose of the Human IgA Liquid Reagent Kit?
The Human IgA Liquid Reagent Kit is an in vitro diagnostic assay designed to measure human IgA concentrations in serum, lithium heparin, or EDTA plasma samples using turbidimetric technology on the SPAPLUS analyzer.
How is the Human IgA Liquid Reagent Kit supplied?
The device is supplied as a liquid reagent kit specifically formulated for use on the Binding Site SPAPLUS turbidimetric analyzer, containing monospecific goat anti-IgA antibodies that react with IgA in patient samples.
What regulatory status does the Human IgA Liquid Reagent Kit have?
The device is regulated as a Class II device and is authorized under FDA 510(k) K081827 with the product code CFN, manufactured by The Binding Site, Ltd.
What sample types can be used with this reagent kit?
The Human IgA Liquid Reagent Kit can be used with serum, lithium heparin, or EDTA plasma samples to measure IgA concentrations through turbidimetric analysis.