Elisa-Dpxa Ssa Kit
by Advanced Biological Products, Inc.
510(k) K924945
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924945 | Date19 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLL
- 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
The ELISA-DPXA SSA Kit is an Extractable Antinuclear Antibody, Antigen And Control designed for use in immunology diagnostics. It facilitates the detection and quantification of extractable nuclear antigens (ENAs), including SSA (anti-Ro) antibodies, through enzyme-linked immunosorbent assay (ELISA) technology. This kit provides reagents necessary for serological testing to aid in the diagnosis of autoimmune diseases, such as systemic lupus erythematosus (SLE) and Sjogren’s syndrome. Its components include antigens, controls, and conjugates to ensure accurate and reproducible results in clinical laboratory settings.
The kit is supplied as a single-use diagnostic reagent and is intended for use in sterile laboratory environments by trained personnel. It is classified under FDA regulation 866.5100 and received 510(k) clearance (K924945) as substantially equivalent to a predicate device in 1993. The kit is not MRI-compatible and requires proper storage at controlled temperatures to maintain stability. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Other devices from Advanced Biological Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ELISA-DPXA SSA Kit used for?
The ELISA-DPXA SSA Kit is designed for the detection and quantification of extractable nuclear antigens (ENAs), specifically SSA (anti-Ro) antibodies, using enzyme-linked immunosorbent assay (ELISA) technology. It aids in the serological diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE) and Sjogren’s syndrome by providing reagents for accurate and reproducible testing in clinical laboratory settings.
How is the ELISA-DPXA SSA Kit supplied and intended for use?
The kit is supplied as a single-use diagnostic reagent, meaning each kit is intended for one-time use only. It is specifically designed for sterile laboratory environments and must be used by trained personnel to ensure proper handling and testing procedures. The sterile nature of the kit is critical to maintaining the integrity of the results.
Is the ELISA-DPXA SSA Kit sterile and how should it be stored?
Yes, the ELISA-DPXA SSA Kit is intended for use in sterile laboratory environments, ensuring that the reagents remain uncontaminated. To maintain stability and sterility, the kit must be stored at controlled temperatures as specified by the manufacturer. Improper storage conditions could compromise the accuracy of the test results and the integrity of the kit.
Can the ELISA-DPXA SSA Kit be reused?
No, the ELISA-DPXA SSA Kit is explicitly designed for single-use only. Reusing the kit violates the manufacturer’s instructions and could lead to inaccurate test results, cross-contamination, or compromised sterility. Each kit is intended to be used once and then discarded.
What regulatory approval does the ELISA-DPXA SSA Kit hold?
The ELISA-DPXA SSA Kit holds FDA 510(k) clearance (K924945) and is classified under FDA regulation 866.5100. It was determined to be substantially equivalent to a predicate device in 1993 by the FDA’s Immunology (IM) Advisory Committee. This clearance confirms that the kit meets the necessary safety and performance standards for its intended use in clinical diagnostics.