Autostat II ANA Screen ELISA
510(k) K983655
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983655 | Date28 Jan 1999 | 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- Withdrawn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
- LJM
- FDA applicant
- Cogent Diagnotics , Ltd.
- 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 Autostat II ANA Screen ELISA is an enzyme-linked immunosorbent assay (ELISA) device designed for the detection of antinuclear antibodies (ANA) in patient serum samples. Classified as an immunology diagnostic tool, it provides qualitative or semi-quantitative results to aid in the identification of autoimmune conditions. This in vitro diagnostic device leverages ELISA technology to measure specific antibody binding to antigens coated on a solid phase.
Intended for use in clinical laboratory settings, the Autostat II ANA Screen ELISA is operated by trained laboratory personnel. Supplied as a single-use diagnostic kit, the device requires no special storage conditions beyond standard laboratory practices. It is regulated under FDA 510(k) clearance (K983655) as a Class 2 device, adhering to the Traditional 510(k) review pathway. No additional regulatory markings beyond the stated FDA authorization are provided in the specifications.
Other devices from Cogent Diagnotics, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Autostat II ANA Screen ELISA used for?
The Autostat II ANA Screen ELISA is designed to detect antinuclear antibodies (ANA) in patient serum samples. ANA presence is clinically relevant for identifying potential autoimmune conditions, such as systemic lupus erythematosus (SLE) or other connective tissue disorders. The device provides qualitative or semi-quantitative results to aid in diagnostic decision-making within clinical laboratory settings.
How is the Autostat II ANA Screen ELISA supplied and intended for use?
The Autostat II ANA Screen ELISA is supplied as a single-use diagnostic kit. It is intended exclusively for in vitro diagnostic use in clinical laboratories by trained personnel. The kit includes all necessary components for performing the ELISA assay, including antigens, controls, and reagents, without requiring additional preparation beyond standard laboratory practices.
Does the Autostat II ANA Screen ELISA require special storage conditions?
No special storage conditions are specified beyond standard laboratory practices. The kit should be stored in a way that maintains its integrity and functionality, typically at controlled room temperature (15–25°C) and protected from light and moisture. Always follow the manufacturer’s instructions for optimal performance and shelf life.
Is the Autostat II ANA Screen ELISA reusable or single-use?
The Autostat II ANA Screen ELISA is designed for single-use only. Each kit is intended for one testing procedure, ensuring accuracy and preventing cross-contamination. Discard any unused components after use in accordance with laboratory waste disposal protocols.
What regulatory pathway does the Autostat II ANA Screen ELISA follow?
The Autostat II ANA Screen ELISA is regulated under the FDA’s 510(k) clearance pathway, specifically under the Traditional 510(k) review. It was cleared as substantially equivalent to a predicate device and falls under the Immunology advisory committee (IM). The clearance number is K983655, and it is classified as a Class 2 device under FDA regulations.