RID System (ACP) Test

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

510(k) Number

K781408 ↗

FDA Product Code

DEM

Device Class

Class II

Regulation

21 CFR Part 866.5130

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Ceruoplasmin Serum Anti-Human

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• Enzymune System I

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  FDA 510(k) K832823 Active Cleared 14 Oct 1983

• Kova Trol III

  Class I

  FDA 510(k) K780482 Active Cleared 3 May 1978

See all devices from Icl Scientific →

• What is the RID System (ACP) Test used for?

  The RID System (ACP) Test is designed for the quantitative measurement of alpha-1 antitrypsin (ACP) antigen levels in serum or plasma. It employs a radial immunodiffusion technique to detect and quantify specific proteins, aiding in diagnosing and monitoring alpha-1 antitrypsin deficiency and related conditions. This method ensures precise immunochemical reactions for reliable clinical results.

• How is the RID System (ACP) Test supplied, and what does the kit include?

  The RID System (ACP) Test is supplied as a complete kit containing all necessary reagents for performing the assay. This includes antigen, antiserum, and control reagents, which are essential for conducting the radial immunodiffusion test in a laboratory setting. The kit is intended for single-use only.

• What storage conditions are required for the RID System (ACP) Test?

  The RID System (ACP) Test does not require special storage conditions beyond standard refrigeration to maintain stability. Proper refrigeration ensures the reagents remain effective for accurate testing, and it is important to follow storage guidelines to preserve the integrity of the antiserum and controls included in the kit.

• Is the RID System (ACP) Test intended for reuse, or is it single-use?

  The RID System (ACP) Test is explicitly designed for single-use only. Each kit contains all necessary reagents for one test, ensuring consistency and reliability in results. Reusing components could compromise accuracy and introduce contamination risks, which is why it is not recommended.

• What regulatory pathway does the RID System (ACP) Test follow?

  The RID System (ACP) Test holds a Traditional 510(k) clearance from the FDA, with a decision date of August 21, 1978. It is classified under the product code DEM (Diagnostic, Electrophoresis, Miscellaneous) and falls under the Immunology advisory committee (IM). This clearance confirms its compliance with regulatory standards for immunology applications in clinical diagnostics.