Isotypes Human IgG Subclass EIA Kit
510(k) K920370
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920370 | Date11 Mar 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CGM
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Isotypes Human IgG Subclass EIA Kit is an enzyme immunoassay (EIA) method for the qualitative detection and differentiation of human immunoglobulin G (IgG) subclasses (IgG1, IgG2, IgG3, and IgG4). This in vitro diagnostic device falls under the classification of immunodiffusion methods for immunoglobulins and is designed for laboratory use in immunology applications. It quantifies specific subclasses of IgG antibodies in serum or plasma samples, aiding in the diagnosis and monitoring of immune-related conditions.
This kit is supplied as a ready-to-use diagnostic tool for clinical laboratories, intended for single-use only. It is not sterile but is packaged to prevent contamination during handling. The device is classified as Class II under FDA regulations (21 CFR 866.5510) and received a 510(k) clearance (K920370) in 1992, demonstrating substantial equivalence to a predicate device. Storage instructions and specific lot details are provided in the accompanying documentation, ensuring proper use and validation within regulated laboratory settings.
Questions
AI-generated answers, 1 Oct 2026
What is the Isotypes Human IgG Subclass EIA Kit used for?
This kit is designed for the qualitative detection and differentiation of human immunoglobulin G (IgG) subclasses—IgG1, IgG2, IgG3, and IgG4—in serum or plasma samples. It aids in diagnosing and monitoring immune-related conditions by quantifying these specific antibody subclasses, helping clinicians assess immune function or response.
How is the Isotypes Human IgG Subclass EIA Kit supplied?
The kit is supplied as a ready-to-use diagnostic tool for laboratory use. It is intended for single-use only and is packaged to minimize contamination risk during handling, though it is not sterile. Each kit includes all necessary components for performing the enzyme immunoassay (EIA) method.
Is the Isotypes Human IgG Subclass EIA Kit sterile?
No, the kit is not sterile. It is packaged to prevent contamination during handling, but it is not intended for sterile procedures. Laboratories must follow proper aseptic techniques when preparing samples for testing to ensure accurate results.
Can the Isotypes Human IgG Subclass EIA Kit be reused?
No, the kit is designed for single-use only. Reusing components could compromise accuracy, introduce contamination, or invalidate test results. Each kit must be used once and then discarded according to laboratory protocols.
What regulatory pathway does the Isotypes Human IgG Subclass EIA Kit follow?
The kit received FDA 510(k) clearance (K920370) in 1992 under the substantial equivalence determination (SESE). It is classified as a Class II device under 21 CFR 866.5510, intended for immunodiffusion methods involving immunoglobulins. The clearance demonstrates it meets regulatory standards for safety and effectiveness.