Haptoglobin Nephelometric Assay

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

510(k) Number

K772245 ↗

FDA Product Code

DAD

Device Class

Class II

Regulation

21 CFR Part 866.5460

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Kallestad Laboratories, Inc. →

• What clinical conditions can the Haptoglobin Nephelometric Assay help identify?

  This assay quantifies haptoglobin levels in human serum or plasma, a glycoprotein that binds free hemoglobin. Elevated or reduced haptoglobin levels can indicate hemolytic anemia or other conditions affecting red blood cell integrity, such as intravascular hemolysis or liver disease. By measuring haptoglobin, clinicians can assess red blood cell damage and guide diagnostic or treatment decisions.

• How is the Haptoglobin Nephelometric Assay supplied, and what equipment is required?

  The assay is supplied as a reagent kit designed for use in clinical laboratories equipped with nephelometers. Nephelometry is a turbidimetric technique that detects and quantifies antigen-antibody reactions in a sample. The kit includes all necessary reagents for performing the assay, but it requires a compatible nephelometer to process the measurements. No additional specialized equipment is mentioned beyond standard laboratory infrastructure.

• Is the Haptoglobin Nephelometric Assay sterile, and how should it be stored?

  The assay is intended for single-use and does not require special sterility beyond standard laboratory aseptic practices. While specific storage conditions are not detailed in the provided data, reagents for nephelometric assays are typically stored refrigerated to maintain stability and performance. Always follow the manufacturer’s instructions for optimal handling and shelf life.

• Can the Haptoglobin Nephelometric Assay be reused, or is it designed for single-use?

  The assay is explicitly designed for single-use only. Reusing reagents could compromise accuracy, introduce contamination, or invalidate results. Each kit is intended for one measurement cycle, ensuring reliable and consistent diagnostic outcomes in clinical settings.

• What regulatory pathway does the Haptoglobin Nephelometric Assay follow, and what is its FDA classification?

  The assay has received FDA 510(k) clearance under Product Code DAD, classified as an immunology device. It was reviewed by the Immunology (IM) Advisory Committee and determined to be substantially equivalent to a predicate device. The clearance number is K772245, reflecting its regulatory status for in vitro diagnostic use in clinical laboratories.