ANA Latex Slide Test

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K800605 ↗

FDA Product Code

DHC

Device Class

Class II

Regulation

21 CFR Part 866.5820

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Air Bed & Flotation Dermagard 800 & 900 Systems

  Class II

  FDA 510(k) K882229 Active Cleared 16 Aug 1988

• Preg-Tex

  Class II

  FDA 510(k) K790898 Active Cleared 30 Jul 1979

• Bi-Aso Slide Test

  Class I

  FDA 510(k) K812060 Active Cleared 13 Aug 1981

• Bi-Ra Slide Test

  Class II

  FDA 510(k) K811375 Active Cleared 12 Jun 1981

• Beta-Cell

  Class I

  FDA 510(k) K791607 Active Cleared 24 Sep 1979

• Carcino-Cek

  Class I

  FDA 510(k) K823353 Active Cleared 14 Dec 1982

See all devices from Biologics Intl., Inc. →

• What is the ANA Latex Slide Test used for?

  The ANA Latex Slide Test detects anti-deoxyribonucleoprotein (anti-DNP) antibodies in human serum. These antibodies serve as markers for autoimmune conditions, particularly systemic lupus erythematosus (SLE). By observing agglutination of DNP-bound latex particles, the test provides qualitative and semiquantitative results to help screen patients for SLE-related autoimmune activity.

• How is the ANA Latex Slide Test supplied and prepared for use?

  The ANA Latex Slide Test is supplied as a single-use diagnostic kit. It requires no initial dilution of the patient’s serum sample, simplifying handling in clinical laboratory settings. Follow the manufacturer’s instructions for proper preparation, as storage and handling specifics are not detailed in regulatory data but typically involve maintaining sterility and stability.

• Is the ANA Latex Slide Test intended for single-use or reuse?

  The ANA Latex Slide Test is explicitly designed for single-use only. Latex slide assays like this are not meant to be reused due to potential contamination risks and degradation of reagents, which could compromise test accuracy. Always adhere to single-use protocols to ensure reliable diagnostic results.

• What regulatory pathway does the ANA Latex Slide Test follow?

  The ANA Latex Slide Test is cleared under the FDA’s 510(k) pathway (K800605), with a decision date of April 2, 1980. It is classified as a Class II device, indicating moderate regulatory oversight. The test falls under the product code DHC for immunology-related diagnostic assays and is intended for use in clinical laboratories.

• What immunology specialty does the ANA Latex Slide Test belong to?

  The ANA Latex Slide Test is categorized under the immunology specialty, specifically for testing related to systemic lupus erythematosus (SLE). It aids in identifying serum markers associated with autoimmune conditions, making it a key tool in rheumatology and immunology diagnostics. The test’s classification aligns with FDA’s product code DHC for diagnostic assays in this field.