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Homocysteine Test

by Roche

510(k) K113793

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113793 Date5 Jun 2012ClearedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0489-2025 FDA Class II initiated 17 Oct 2024

    Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

    • Terminated Z-0679-2020 FDA Class II initiated 4 Oct 2019

    Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

    • Terminated Z-1622-2015 FDA Class II initiated 23 Mar 2015

    Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

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