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i-STAT 06F14-01

by Abbott Point of Care Inc.

Ref 06F14-01

i-STAT 06F14-01 is a device classified as IVD General (EU), Class I (US) made by Abbott Point of Care Inc., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-00054749000661), cleared under FDA 510(k) K972868 on 28 Aug 1997 and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00054749000661), active as of 24 Oct 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

510(k) K972868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00054749000661 Basic UDI-DI 00054749000661UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00054749000661 UDI-DI Date23 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972868 Date28 Aug 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00054749000661 registered 1 Sep 2026 Active
  • FDA 510(k) K972868 decided 28 Aug 1997 Active
  • FDA GUDID UDI-DI 00054749000661 listed 23 Jun 2023 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1314-2024 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1315-2024 FDA Class II initiated 9 Jan 2024

    Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Timeline

5 dated events

  1. Cleared FDA 510(k) K972868
  2. Listed FDA GUDID 00054749000661
  3. Recall initiated FDA recalls Z-1314-2024
  4. Recall initiated FDA recalls Z-1315-2024
  5. Registered EUDAMED B-00054749000661

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
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device name
i-STAT Control Level 3
Model / Ref / Catalog
06F14-01
Primary DI / UDI-DI
00054749000661
Basic UDI-DI
B-00054749000661
510(k) Number
FDA product code
JJY
EMDN code
W010106040201 Multiple parameters poc controls
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte 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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Cleared under the same submission (K972868)

and 4 more cleared under K972868

Similar devices in this category

Other devices filed under MULTIPLE PARAMETERS POC.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)