Rubella IgM ELISA Test
by Gull Laboratories, Inc. 510(k)
Active
510(k) K904084
Overview
The Rubella IgM ELISA Test is an Enzyme-Linked Immunosorbent Assay (ELISA) designed for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma. This device falls under the Microbiology category and is classified as a Class II medical device, enabling serological screening for recent rubella infection.
This test is intended for in vitro diagnostic use in clinical laboratories, supplied as a single-use reagent kit for manual or automated processing. It requires no special storage conditions beyond refrigeration (2–8°C) and is not intended for MRI environments. The test is authorized under FDA 510(k) clearance (K904084) and adheres to regulatory standards outlined in 21 CFR 866.3510. No sterilization or reprocessing is specified, as it is designed for one-time use per sample.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904084 | Date4 Dec 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3510
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Gull Laboratories, Inc.
Questions
What is the Rubella IgM ELISA Test used for in clinical settings?
The Rubella IgM ELISA Test is designed for the qualitative detection of IgM antibodies to the rubella virus in human serum or plasma. It helps clinicians identify recent rubella infections by screening for these antibodies, which are typically present during the early stages of infection. This aids in diagnosing acute rubella and guiding patient management.
How is the Rubella IgM ELISA Test supplied, and is it meant for single-use?
The test is supplied as a single-use reagent kit, intended for manual or automated processing in clinical laboratories. Since it is not specified for sterilization or reprocessing, each kit is designed for one-time use per sample, ensuring accuracy and preventing cross-contamination.
What storage conditions are required for the Rubella IgM ELISA Test?
The test does not require special storage conditions beyond standard refrigeration, which means it should be stored between 2°C and 8°C. This ensures the reagents remain stable and effective for use in detecting IgM antibodies to rubella.
Is this test approved for use in automated systems, and if so, what does that mean for laboratories?
Yes, the Rubella IgM ELISA Test is designed for use in both manual and automated processing systems. This flexibility allows laboratories to integrate the test into their existing workflows, whether they rely on manual handling or automated platforms, improving efficiency and scalability for large volumes of samples.
What regulatory pathway was followed for the FDA clearance of this device?
The Rubella IgM ELISA Test received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type, with a decision of Substantially Equivalent (SESE). The device falls under the Microbiology category and adheres to regulatory standards outlined in 21 CFR 866.3510, ensuring compliance with in vitro diagnostic device requirements.