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Hcy HY4036

by Randox Laboratories, Ltd.

Hcy HY4036 is a homocysteine IVD (FDA Class II; FDA product code LPS, Urinary Homocystine (Nonquantitative) Test System) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K083222 on 31 Jul 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273208894), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K083222

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055273208894 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083222 Date31 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083222 decided 31 Jul 2009 Active
  • FDA GUDID UDI-DI 05055273208894 listed 24 Sep 2016 Listed

Recalls

5 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0742-2020 FDA Class II initiated 16 Sep 2019
    • Ongoing Z-0743-2020 FDA Class II initiated 16 Sep 2019
    • Ongoing Z-0744-2020 FDA Class II initiated 16 Sep 2019

    There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

    • Terminated Z-2063-2016 FDA Class II initiated 3 Apr 2015

    Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.

    • Terminated Z-1946-2015 FDA Class II initiated 20 Mar 2015

    Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

Timeline

7 dated events

  1. Cleared FDA 510(k) K083222
  2. Recall initiated FDA recalls Z-1946-2015
  3. Recall initiated FDA recalls Z-2063-2016
  4. Listed FDA GUDID 05055273208894
  5. Recall initiated FDA recalls Z-0742-2020
  6. Recall initiated FDA recalls Z-0743-2020
  7. Recall initiated FDA recalls Z-0744-2020

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hcy
Generic name
Homocysteine IVD, reagent
Model / Ref / Catalog
HY4036
Primary DI / UDI-DI
05055273208894
510(k) Number
FDA product code
LPS
GMDN term
Homocysteine IVD, reagent
Device class
Class II
Regulation number
862.1377
GUDID distribution status
In Commercial Distribution

Related devices

Category: Homocysteine IVD, reagent

Cleared under the same submission (K083222)

and 1 more cleared under K083222

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)