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i-STAT 05P59-04

by Abbott Point of Care Inc.

Ref 05P59-04

i-STAT 05P59-04 is a device classified as IVD General (EU), Class I (US) made by Abbott Point of Care Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00054749001040), cleared under FDA 510(k) K121237 on 18 May 2012 and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00054749001040), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K121237

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-00054749001040 Basic UDI-DI 00054749001040UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00054749001040 UDI-DI Date23 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121237 Date18 May 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00054749001040 registered 26 Oct 2026 Active
  • FDA 510(k) K121237 decided 18 May 2012 Active
  • FDA GUDID UDI-DI 00054749001040 listed 23 Jun 2023 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K121237
  2. Listed FDA GUDID 00054749001040
  3. Registered EUDAMED B-00054749001040

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  • Withdrawn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
i-STAT Total b-hCG Calibration Verification 1-3 EUDAMED
i-STAT GUDID
Generic name
Human chorionic gonadotropin beta-core fragment IVD, control
Model / Ref / Catalog
05P59-04
Primary DI / UDI-DI
00054749001040
Basic UDI-DI
B-00054749001040
510(k) Number
FDA product code
JJX
EMDN code
W0102152002 Hormone controls
GMDN term
Human chorionic gonadotropin beta-core fragment IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

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

Related devices

Category: Human chorionic gonadotropin beta-core fragment IVD, control

Cleared under the same submission (K121237)

Similar devices in this category

Other devices filed under HORMONE CONTROLS.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)