Rid Plates & Intensi. for Human Ige Etc
by G.D. Searle and Co. 510(k)
Active
510(k) K771238
Overview
This device consists of Radioimmunodiffusion (RID) Plates and Intensifiers designed for the quantitative measurement of human Immunoglobulin E (IGE) and related antigens. As a Radioimmunodiffusion Test System (per regulatory classification), it facilitates immunologic assays by enabling precise detection and titration of serum antibodies or antigens through diffusion in agar gel.
The RID Plates and Intensifiers are intended for use in clinical immunology laboratories under controlled conditions. Supplied as a single-use diagnostic reagent, they require no sterilization beyond manufacturer-provided packaging. The system adheres to FDA 510(k) clearance (K771238) under regulation 21 CFR 866.5510, classified as Class II for immunologic testing. Storage and handling follow standard laboratory protocols for sensitive reagents, with no MRI compatibility or reusable components specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771238 | Date15 Jul 1977 | 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- Withdrawn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
- DGC
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from G.D. Searle and Co.
Questions
What is the RID Plates & Intensifiers system used for?
The RID Plates & Intensifiers system is designed for the quantitative measurement of human Immunoglobulin E (IGE) and related antigens in clinical immunology laboratories. It enables precise detection and titration of serum antibodies or antigens through the process of immunodiffusion in agar gel, facilitating accurate immunologic assays under controlled laboratory conditions.
How is the RID Plates & Intensifiers system supplied and intended for use?
The system is supplied as a single-use diagnostic reagent, meaning each set is intended for one-time use only. No additional sterilization beyond the manufacturer-provided packaging is required. It is specifically intended for use in clinical immunology laboratories where precise and controlled testing conditions can be maintained.
Are the RID Plates & Intensifiers reusable or single-use?
The RID Plates & Intensifiers are explicitly designed as a single-use diagnostic reagent. This ensures consistency in results and minimizes the risk of contamination or cross-reactivity, which could compromise the accuracy of immunologic assays. Reuse is not recommended or supported by the manufacturer.
What storage and handling guidelines apply to the RID Plates & Intensifiers?
The RID Plates & Intensifiers must be stored and handled according to standard laboratory protocols for sensitive reagents. Since they are single-use and supplied in sterile packaging, they do not require further sterilization. Proper storage conditions—such as protecting from extreme temperatures, moisture, and light—are essential to maintain the integrity and performance of the reagent until use.
What regulatory clearance does the RID Plates & Intensifiers system have?
The RID Plates & Intensifiers system holds FDA 510(k) clearance under regulation 21 CFR 866.5510, classified as a Class II medical device for immunologic testing. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for safety and effectiveness in its intended use.