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K-ASSAY Haptoglobin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993480

by Kamiya Biomedical Co.

Identifiers

510(k) Number
K993480 FDA 510(k)
FDA Product Code
DAD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5460 FDA 510(k)
Regulation Number
866.5460 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The K-ASSAY Haptoglobin is an immunoturbidimetric assay reagent for the quantitative determination of human haptoglobin in human serum. Haptoglobin is a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells.

The device is supplied as a reagent kit and is intended for use with chemistry analyzers. It received FDA 510(k) clearance (K993480) and is classified as a Class II device under regulation number 866.5460 with product code DAD.

Frequently asked questions

What is the K-ASSAY Haptoglobin assay used for?

The K-ASSAY Haptoglobin assay is used for the quantitative determination of human haptoglobin in human serum. Haptoglobin binds hemoglobin, and measuring its levels helps assess conditions involving hemolysis or inflammation, as it is an acute-phase reactant.

How is the K-ASSAY Haptoglobin reagent supplied and what equipment is it intended for?

The K-ASSAY Haptoglobin reagent is supplied as a reagent kit and is intended for use with chemistry analyzers. It is designed to run on automated clinical chemistry platforms that support immunoturbidimetric assays.

Is the K-ASSAY Haptoglobin reagent sterile or single-use?

The reagent kit is not described as sterile or single-use in the provided data. It is an in vitro diagnostic reagent intended for multiple uses within its stability period when stored and handled according to the manufacturer’s instructions.

What regulatory clearance does the K-ASSAY Haptoglobin have and under which classification?

The K-ASSAY Haptoglobin received FDA 510(k) clearance under submission K993480 and is classified as a Class II medical device under regulation number 866.5460 with product code DAD.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K-ASSAY - Kamiya Biomedical Company, Kamiya Biomedical Company - Clinical Diagnostics - Haptoglobin Reagent, PDF KAMIYA BIOMEDICAL COMPANY PROCEDURE K ASSAY Haptoglobin, K-ASSAY Haptoglobin Reagent Kit - 200 Tests - usamedpremium.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kamiya Biomedical Co.

Sources (1)

  • FDA 510(k) K993480 24 fields · synced Oct 6, 2026