Human IgG Subclass Liquid Reagent Kits for Use on the SPAPLUS Analyser
by The Binding Site, Ltd. 510(k)
Active
510(k) K072889
Overview
The Human IgG Subclass Liquid Reagent Kits are nephelometric immunological test systems designed for the quantitative measurement of human immunoglobulin G (IgG) and its subclasses (IgG1, IgG2, IgG3, and IgG4) in serum or plasma samples. These kits utilise a turbidimetric immunoassay method to detect and quantify specific subclasses of IgG, aiding in the diagnosis and monitoring of immunodeficiencies, autoimmune diseases, and other conditions affecting immunoglobulin levels.
These kits are supplied as liquid reagents intended for use exclusively on the SPAPLUS Analyser, a nephelometric immunoassay system. They are classified as Class II devices under 21 CFR 866.5510 and have received FDA 510(k) clearance as substantially equivalent to a predicate device. The kits are not described as single-use or reusable in the regulatory data, though their intended use implies single-use per assay. No specific sterility or MRI safety information is provided, and storage conditions are not detailed beyond standard laboratory practices for immunological reagents.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072889 | Date1 Feb 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- Withdrawn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 Human IgG Subclass Liquid Reagent Kit used for?
This kit is designed for the quantitative measurement of human immunoglobulin G (IgG) and its subclasses (IgG1, IgG2, IgG3, and IgG4) in serum or plasma samples. It uses a turbidimetric immunoassay method to detect and quantify these subclasses, aiding in diagnosing and monitoring immunodeficiencies, autoimmune diseases, and other conditions affecting immunoglobulin levels.
On which analyser is this reagent kit intended for use?
The Human IgG Subclass Liquid Reagent Kits are exclusively intended for use on the SPAPLUS Analyser, a nephelometric immunoassay system. This compatibility ensures accurate and reliable measurement of IgG subclasses as specified in the kit’s design.
Are these reagent kits single-use or reusable?
While the regulatory data does not explicitly state whether the kits are single-use or reusable, their intended use—performing quantitative assays—implies they are designed for single-use per test. This aligns with standard practices for immunological reagents to maintain accuracy and sterility.
What regulatory clearance does this kit hold?
The Human IgG Subclass Liquid Reagent Kits have received FDA 510(k) clearance, demonstrating they are substantially equivalent to a predicate device. They are classified under 21 CFR 866.5510 as Class II devices, indicating a moderate level of regulatory oversight.
What storage conditions should be followed for these reagents?
The data does not specify exact storage conditions, but standard laboratory practices for immunological reagents should be followed. This typically includes storing reagents at 2–8°C (refrigerated) and protecting them from light and contamination to preserve their integrity and performance.