Anti-Nuclear Antibody(Ana) Test Kit W/Mouse Liver

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K944191 ↗

FDA Product Code

DBL

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the primary use of the Anti-Nuclear Antibody (ANA) Test Kit with Mouse Liver, and how does it work?

  The ANA Test Kit with Mouse Liver is designed for in vitro diagnostic use in clinical immunology laboratories to detect multiple autoantibodies, specifically anti-nuclear antibodies (ANA). It employs an indirect immunofluorescent assay using mouse liver tissue as the substrate to identify these antibodies in patient samples. This helps clinicians diagnose autoimmune diseases by confirming the presence of ANAs.

• Is this test kit single-use, and what does that mean for my laboratory workflow?

  Yes, this ANA Test Kit is supplied as a single-use reagent, meaning each kit is intended for one test procedure only. This design ensures consistency and reliability in results while minimizing the risk of cross-contamination. Your laboratory should plan accordingly to avoid using partially used kits, as they are not meant for reuse or reprocessing.

• How should I store the ANA Test Kit with Mouse Liver to maintain its integrity?

  The kit follows standard in vitro diagnostic storage protocols, though specific storage conditions are not detailed in the provided data. Generally, such immunofluorescent assay kits are stored under controlled conditions—typically refrigerated (2–8°C) and protected from light—to preserve the mouse liver substrate and reagents. Always refer to the included instructions for precise storage guidelines.

• What regulatory pathway does this device follow, and how does that affect its use in my facility?

  This kit is cleared under the FDA’s 510(k) pathway (K944191), granted in 1995, and classified as a Class II medical device for immunology diagnostics. The clearance ensures it meets FDA’s special controls for indirect immunofluorescent assays (regulation 866.5660), including performance standards for detecting autoantibodies. While cleared, facilities must still follow local laboratory protocols and CLIA requirements for in vitro diagnostics.

• Does the kit require any special handling or preparation before use, such as sterilization?

  No additional sterilization is required beyond the manufacturer’s controls, as the kit is designed for single-use and intended to be used as-is in a clinical immunology lab. The mouse liver substrate and reagents are pre-prepared, so proper handling involves following the provided instructions for sample preparation and assay procedures to ensure accurate results.