Alpha-2-Macroglobulin Nephel. Assay

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K772246 ↗

FDA Product Code

DEB

Device Class

Class II

Regulation

21 CFR Part 866.5620

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Quantitope 125-I Gentamicin Ria Kit

  Class II

  FDA 510(k) K780323 Active Cleared 17 Mar 1978

• Kallestad Antisera to Tobramycin

  Class II

  FDA 510(k) K812415 Active Cleared 9 Sep 1981

• Ria Kit, Quantitope Cortisol

  Class II

  FDA 510(k) K781903 Active Cleared 26 Jan 1979

• Mark 500 System

  Not classified

  FDA 510(k) K812416 Active Cleared 8 Apr 1982

• Quantimetric Plus C4 Reagent Kit

  Class II

  FDA 510(k) K855012 Active Cleared 26 Feb 1986

• Quanticoat Neonatal 125 T4 Radioimmuno

  Class II

  FDA 510(k) K812611 Active Cleared 2 Oct 1981

See all devices from Kallestad Laboratories, Inc. →

• What is the Alpha-2-Macroglobulin Nephelometric Assay used for?

  This assay quantifies alpha-2-macroglobulin concentrations in serum or plasma. Alpha-2-macroglobulin is a protease inhibitor and large plasma protein involved in enzyme transport, immune response modulation, and proteolytic activity inhibition. Clinicians use it to assess conditions related to its dysfunction or elevated levels, such as hereditary angioedema or inflammatory disorders.

• How is the Alpha-2-Macroglobulin Nephelometric Assay supplied, and what equipment is required?

  The assay is supplied as a reagent kit designed for use in clinical laboratories equipped with nephelometric analyzers. The kit contains all necessary reagents for single-use testing, and no additional sterilization is required beyond the manufacturer’s sealed packaging. The nephelometer measures antigen-antibody reactions via turbidimetry, enabling precise quantification of alpha-2-macroglobulin.

• Is the Alpha-2-Macroglobulin Nephelometric Assay single-use or reusable?

  The assay is intended for single-use only. Each reagent kit is packaged to ensure sterility and accuracy for one test cycle. Reuse is not recommended, as it could compromise results or introduce contamination, potentially affecting patient outcomes.

• What storage conditions and shelf life apply to this assay kit?

  Storage conditions and shelf life details are specified in the accompanying instructions provided by the manufacturer. Generally, such nephelometric assay kits require refrigeration (typically 2–8°C) and should be protected from light. Always refer to the included documentation for precise storage guidelines to maintain reagent efficacy and ensure valid test results.

• What regulatory pathway was followed for this assay’s clearance?

  This assay received FDA clearance through a Traditional 510(k) submission (K772246) under the Immunology (IM) advisory committee. It falls under product code DEB (Diagnostic Equipment, Biological) and is classified as a Class II device under 21 CFR 866.5620. The clearance confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for in vitro diagnostics.