Immunwell Sjogren’s Syndrome B (La) Antibody Test
510(k) K911850
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911850 | Date7 May 1991 | 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- Withdrawn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
- LKO
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5100
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an antinuclear antibody immunological test system designed to detect and measure autoantibodies in serum or other body fluids that react with La (SS-B) antigens. It aids in the diagnosis of autoimmune conditions, including Sjogren’s syndrome, by identifying specific antibodies associated with nuclear and cytoplasmic components. The test employs immunochemical techniques to quantify these antibodies, supporting clinical assessments in immunology.
The Immunwell Sjogren’s Syndrome B (La) Antibody Test is supplied as a reagent-based system for in vitro diagnostic use, intended for single-use only. It is classified as a Class II device under FDA regulations (21 CFR 866.5100) and carries an FDA 510(k) clearance (K911850) with a decision date of May 7, 1991. The product code is LKO, and it is distributed by General Biometrics, Inc. (San Diego, CA). No information regarding MRI safety or sterility is provided in the available data.
Other devices from General Biometrics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Immunwell Sjogren’s Syndrome B (La) Antibody Test used for?
This test detects and measures autoantibodies in serum or other body fluids that react with La (SS-B) antigens. It aids clinicians in diagnosing autoimmune diseases, particularly Sjogren’s syndrome, by identifying specific antibodies linked to nuclear and cytoplasmic components. The results support immunology assessments to guide patient care.
How is the Immunwell Sjogren’s Syndrome B (La) Antibody Test supplied?
The test is supplied as a reagent-based system designed for in vitro diagnostic use. It is intended for single-use only, meaning each kit is meant to be used once and then discarded. This ensures accuracy and prevents cross-contamination between tests.
Is the Immunwell Sjogren’s Syndrome B (La) Antibody Test sterile?
The provided data does not specify whether the Immunwell Sjogren’s Syndrome B (La) Antibody Test is sterile. For clinical use, it is important to confirm sterility requirements with the manufacturer or consult their instructions for use, as improper handling could impact diagnostic reliability.
What regulatory clearance does the Immunwell Sjogren’s Syndrome B (La) Antibody Test hold?
The test holds an FDA 510(k) clearance (K911850) and is classified as a Class II device under FDA regulations (21 CFR 866.5100). This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.
Are there different sizes or models available for the Immunwell Sjogren’s Syndrome B (La) Antibody Test?
The provided data does not mention multiple sizes or models for this specific test. It is supplied as a single reagent-based system for detecting La (SS-B) antibodies. For variations or additional options, it is recommended to consult the manufacturer’s product catalog or contact their support team.