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IMX Homocysteine Modification

by Axis Biochemicals, Asa 510(k)

Active United States

510(k) K992274

Overview

The IMX Homocysteine Modification is a Urinary Homocystine (Nonquantitative) Test System designed for use with the IMx Analyzer. It employs a Fluorescence Polarization Immunoassay (FPIA) to detect total L-homocysteine in human serum or plasma, aiding in the assessment of hyperhomocysteinemia and homocystinuria—conditions linked to elevated cardiovascular risk.

This device is supplied as a single-use reagent system for clinical chemistry applications, intended for use in laboratory settings. It is regulated under FDA 510(k) clearance (K992274) and classified as a Class II medical device under 21 CFR 862.1377. No MRI safety or sterility specifications are noted in the regulatory submission.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992274 Date6 Oct 1999ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Modification to Imx Homocysteine
510(k) Number
FDA Product Code
LPS
Device Class
Class II
Regulation
21 CFR Part 862.1377
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Axis Biochemicals, Asa

Questions

  • What is the IMX Homocysteine Urinary Test System used for?

    This device is designed to detect total L-homocysteine in human urine using Fluorescence Polarization Immunoassay (FPIA). It helps clinicians assess hyperhomocysteinemia and homocystinuria, conditions associated with elevated cardiovascular risk. The test is intended for use in laboratory settings to support diagnostic evaluations.

  • How is the IMX Homocysteine Urinary Test System supplied?

    The test system is supplied as a single-use reagent system. Each kit is intended for one-time use with the IMx Analyzer, ensuring consistency and reducing the risk of cross-contamination. This aligns with standard clinical chemistry practices for reagent-based assays.

  • Is the IMX Homocysteine Urinary Test System sterile?

    The regulatory submission for this device does not specify sterility requirements, so it is not confirmed whether the reagent system is sterile. However, it is designed for clinical chemistry applications in laboratory settings, where sterility is typically a critical consideration for patient safety.

  • Can the IMX Homocysteine Urinary Test System be reused?

    No, the device is explicitly described as a single-use reagent system. Reusing it could compromise accuracy, introduce contamination, or violate manufacturer guidelines. Always follow the intended single-use protocol to ensure reliable test results.

  • What regulatory pathway does the IMX Homocysteine Urinary Test System follow?

    This device was cleared under the FDA’s 510(k) pathway (K992274) and is classified as a Class II medical device under 21 CFR 862.1377. The clearance was granted as substantially equivalent to a predicate device, with review by the Clinical Chemistry (CH) Advisory Committee. This classification reflects its role in diagnostic testing for cardiovascular risk assessment.