Ana-Check

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K831463 ↗

FDA Product Code

LKJ

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Technology, Inc. →

• What clinical setting is the ANA-CHECK designed for, and why is it important to use it there?

  The ANA-CHECK is designed exclusively for use in clinical laboratory settings where trained immunology personnel can perform the test. This is important because the device relies on manual handling and interpretation of agglutination reactions, which require specialized expertise to ensure accurate results for diagnosing potential autoimmune diseases through antinuclear antibody detection.

• Is the ANA-CHECK intended for reuse, and if not, what does that mean for its handling and disposal?

  No, the ANA-CHECK is supplied as a single-use diagnostic reagent, meaning each test kit is meant for one use only. This design ensures patient safety and test accuracy, as reuse could introduce contamination or alter results. After use, it must be disposed of following standard biohazard protocols for diagnostic reagents, as it is not sterile and may contain infectious materials.

• How does the ANA-CHECK work, and what kind of sample can it analyze?

  The ANA-CHECK operates using a rapid latex slide test that detects antinuclear antibodies (ANA) through agglutination. Latex particles coated with DNA bind to ANA present in the patient’s sample, creating a visible reaction. It is designed to analyze human serum and plasma, making it useful for evaluating autoimmune conditions where ANA presence is a key marker.

• What storage conditions should be followed for the ANA-CHECK, and why are these important?

  Storage conditions for the ANA-CHECK are specified on the packaging, though exact details are not provided here. These conditions are critical to maintaining the reagent’s stability, accuracy, and effectiveness. Improper storage—such as exposure to extreme temperatures or moisture—could degrade the latex particles or antigens, leading to false results or test failure.

• What regulatory pathway does the ANA-CHECK follow, and what does that mean for its use in clinical practice?

  The ANA-CHECK follows the FDA’s 510(k) clearance pathway, specifically under the product code LKJ (Antinuclear Antibody, Antigen, Control) and classified as a Class II medical device. This means it has undergone review by the FDA’s Immunology (IM) advisory committee and is deemed substantially equivalent to a predicate device, ensuring it meets safety and performance standards for clinical use in immunology testing.