Rubelisa IgM Test Kit
by M.A. Bioproducts 510(k)
Active
510(k) K802508
Overview
The Rubelisa IgM Test Kit is a serological reagent device classified under Antigen, Ha (Including Ha Control), Rubella (Regulation 866.3510). It is designed for use in identifying IgM antibodies to the rubella virus in human serum, aiding in the diagnosis of acute rubella infection. This test kit employs antigen-antibody reactions to detect specific immune responses, supporting microbiological laboratory assessments. The device falls under Class II regulatory classification, indicating a moderate risk level requiring pre-market notification.
The Rubelisa IgM Test Kit is supplied as a single-use diagnostic reagent for in vitro use in clinical microbiology laboratories. It is intended for use by trained personnel in controlled settings, such as hospitals or reference laboratories, where serological testing is performed. The kit is not sterile for direct patient administration but is packaged to maintain integrity until use. No specific MRI safety information is provided, and storage conditions are not detailed in the regulatory data. The device holds FDA 510(k) clearance (K802508) under the Microbiology advisory committee, with a Substantially Equivalent (SESE) decision.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802508 | Date18 Dec 1980 | 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- Withdrawn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
- GOL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3510
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from M.A. Bioproducts
Questions
What is the Rubelisa IgM Test Kit used for?
The Rubelisa IgM Test Kit is designed to identify IgM antibodies against the rubella virus in human serum. This helps clinicians diagnose acute rubella infections by detecting specific immune responses through antigen-antibody reactions, supporting accurate microbiological laboratory assessments.
Is the Rubelisa IgM Test Kit intended for single-use or reuse?
The Rubelisa IgM Test Kit is supplied as a single-use diagnostic reagent. It is intended for in vitro use in clinical microbiology laboratories, ensuring each test is performed with a fresh kit to maintain accuracy and prevent cross-contamination.
What regulatory clearance does the Rubelisa IgM Test Kit hold?
The Rubelisa IgM Test Kit holds FDA 510(k) clearance under the Microbiology advisory committee, with a decision classified as Substantially Equivalent (SESE). This clearance indicates that the device meets regulatory standards for moderate-risk Class II devices.
Who should perform tests using the Rubelisa IgM Test Kit?
The Rubelisa IgM Test Kit is intended for use by trained personnel in controlled settings such as hospitals or reference laboratories. Its design ensures proper handling and interpretation of results by qualified staff.
Is the Rubelisa IgM Test Kit sterile for direct patient administration?
No, the Rubelisa IgM Test Kit is not sterile for direct patient administration. It is packaged to maintain integrity until use in a laboratory setting, where it is employed for in vitro diagnostic testing of human serum samples.