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Fiax Haptoglobin Test Kit

by Intl. Diagnostic Technology 510(k)

Active United States

510(k) K843570

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843570 Date5 Oct 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DAB
Device Class
Class II
Regulation
21 CFR Part 866.5460
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fiax Haptoglobin Test Kit is an immunological test system classified as a Haptoglobin, FITC, Antigen, Antiserum, Control device under FDA nomenclature. It employs immunochemical techniques to measure haptoglobin levels in serum, a protein that binds hemoglobin to prevent its oxidative damage in the bloodstream.

This kit is intended for in vitro diagnostic use in immunology settings and is supplied as a traditional 510(k)-cleared device (K843570) under FDA authorization. It is designed for single-use and requires no special storage conditions beyond those specified in the accompanying instructions. The device falls under Class II regulatory classification and was cleared for market distribution in 1984.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fiax Haptoglobin Test Kit used for in clinical settings?

    The Fiax Haptoglobin Test Kit is an in vitro diagnostic tool designed to measure haptoglobin levels in serum using immunochemical techniques. Haptoglobin is a protein that binds free hemoglobin to protect against oxidative damage in the bloodstream, so this test helps assess conditions related to hemolysis or hemoglobinuria, particularly in immunology settings.

  • How is the Fiax Haptoglobin Test Kit supplied, and is it reusable?

    The kit is supplied as a single-use device, meaning each test requires a new kit. It does not require special storage conditions beyond those outlined in the included instructions, making it convenient for one-time diagnostic use without the need for sterilization or reprocessing.

  • What regulatory pathway was followed for the FDA clearance of this test kit?

    The Fiax Haptoglobin Test Kit was cleared through a traditional 510(k) pathway, specifically under the classification of Haptoglobin, FITC, Antigen, Antiserum, and Control devices. It was determined to be *substantially equivalent* to a predicate device and was reviewed by the FDA’s Immunology (IM) Advisory Committee before clearance in 1984.

  • Are there different sizes or models of this test kit, or is it a uniform single-product offering?

    The data provided does not specify multiple sizes or models for the Fiax Haptoglobin Test Kit. It is described as a singular, standardized immunological test system for measuring haptoglobin levels, implying a uniform product offering without variations in kit composition or configuration.