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Amy AY3805

by Randox Laboratories, Ltd.

Ref AY3805

Amy AY3805 is a device classified as IVD General (EU), Class II (US) made by Randox Laboratories, Ltd., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-05055273200607), cleared under FDA 510(k) K953211 on 21 Jun 1996 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05055273200607), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K953211

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055273200607 Basic UDI-DI 05055273200607UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273200607 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK953211 Date21 Jun 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055273200607 registered 27 Oct 2026 Active
  • FDA 510(k) K953211 decided 21 Jun 1996 Active
  • FDA GUDID UDI-DI 05055273200607 listed 9 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

1 recall · FDA

    • Terminated Z-2923-2020 FDA Class II initiated 10 Jul 2020

    Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

Timeline

4 dated events

  1. Cleared FDA 510(k) K953211
  2. Listed FDA GUDID 05055273200607
  3. Recall initiated FDA recalls Z-2923-2020
  4. Registered EUDAMED B-05055273200607

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Amylase (Amy) EUDAMED
Amy GUDID
Generic name
Alpha-amylase isoenzyme IVD, reagent
Model / Ref / Catalog
AY3805
Primary DI / UDI-DI
05055273200607
Basic UDI-DI
B-05055273200607
510(k) Number
FDA product code
CIJ
EMDN code
W01010107 Amylase - total
GMDN term
Alpha-amylase isoenzyme IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1070
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Amylase isoenzyme IVD, reagent

Cleared under the same submission (K953211)

and 1 more cleared under K953211

Similar devices in this category

Other devices filed under AMYLASE - TOTAL.

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)