Diastat ENA Single Well Screen Kit
510(k) K944505
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944505 | Date21 Nov 1994 | StatusActive |
Recalls
-
- Terminated Z-0672-05
An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
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- Withdrawn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 Diastat ENA Single Well Screen Kit is an Extractable Antinuclear Antibody, Antigen, and Control device, classified under the Immunology specialty. It is designed for screening serum or plasma samples to detect extractable nuclear antigens (ENA), aiding in the diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE) or scleroderma. The kit employs a single-well format for qualitative testing, facilitating the identification of specific autoantibodies associated with connective tissue disorders. Its purpose aligns with regulatory definitions for Extractable Antinuclear Antibody testing in clinical immunology workflows.
This kit is supplied as a single-use diagnostic reagent intended for in vitro laboratory use. It is not sterile and must be handled under controlled conditions to prevent contamination. The device is Class II under FDA regulations (product code LLL) and was cleared via a Traditional 510(k) pathway in 1994 (FDA clearance K944505). Storage and handling instructions are specified in the accompanying documentation, though no additional regulatory approvals beyond the 510(k) clearance are stated. The kit is intended for use in accredited laboratories adhering to CLIA (Clinical Laboratory Improvement Amendments) guidelines for immunology testing.
Other devices from Shield Diagnostics, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Diastat ENA Single Well Screen Kit used for?
This kit is designed for qualitative screening of serum or plasma samples to identify extractable nuclear antigens (ENA), which are linked to autoimmune conditions such as systemic lupus erythematosus (SLE) and scleroderma. By detecting specific autoantibodies, it aids clinicians in diagnosing connective tissue disorders within immunology workflows.
Is the Diastat ENA Single Well Screen Kit sterile?
No, the kit is not sterile and must be handled under controlled conditions to prevent contamination. Since it is intended for in vitro laboratory use, proper aseptic techniques are required during testing to ensure accurate results.
How is the Diastat ENA Single Well Screen Kit supplied?
The kit is supplied as a single-use diagnostic reagent, meaning each unit is intended for one testing procedure only. This design minimizes cross-contamination risks and ensures consistent performance for accurate ENA detection in clinical settings.
What regulatory pathway was used for FDA clearance?
The Diastat ENA Single Well Screen Kit received FDA clearance via a Traditional 510(k) pathway in 1994 under the product code LLL, which falls under Class II medical devices. The clearance (K944505) confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for immunology testing.
Where should the kit be stored, and what are the handling requirements?
Storage and handling instructions are detailed in the accompanying documentation, though key considerations include controlled environmental conditions to prevent degradation. Since the kit is non-sterile, it must be used in CLIA-accredited laboratories adhering to standard immunology protocols. Always follow manufacturer guidelines to maintain reagent integrity and test validity.