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Abx Pentra Reference 280ml 1220001901

by Horiba Abx

Ref A11A01901

Abx Pentra Reference 280ml 1220001901 is a device classified as IVD General (EU), Class II (US) made by Horiba Abx, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-03610230005613), cleared under FDA 510(k) K052007 on 16 Dec 2005 and listed in FDA GUDID since 16 Aug 2016 (UDI-DI 03610230005613), active as of 25 Oct 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 ongoing

6 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K052007

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-03610230005613 Basic UDI-DI 03610230005613UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03610230005613 UDI-DI Date16 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK052007 Date16 Dec 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03610230005613 registered 16 Jun 2026 Active
  • FDA 510(k) K052007 decided 16 Dec 2005 Active
  • FDA GUDID UDI-DI 03610230005613 listed 16 Aug 2016 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

6 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0493-2018 FDA Class II initiated 21 Nov 2017 on shared 510(k) K052007
    • Terminated Z-0494-2018 FDA Class II initiated 21 Nov 2017 on shared 510(k) K052007

    The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.

    • Terminated Z-0740-2016 FDA Class II initiated 11 Jan 2016 on shared 510(k) K052007

    N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.

    • Terminated Z-0902-2015 FDA Class II initiated 13 Nov 2014 on shared 510(k) K052007

    HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes

    • Terminated Z-0904-2014 FDA Class II initiated 21 Nov 2013 on shared 510(k) K052007

    Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

    • Terminated Z-1141-2013 FDA Class II initiated 20 Mar 2013 on shared 510(k) K052007

    HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

9 dated events

  1. Cleared FDA 510(k) K052007
  2. Recall initiated FDA recalls Z-1141-2013
  3. Recall initiated FDA recalls Z-0904-2014
  4. Recall initiated FDA recalls Z-0902-2015
  5. Recall initiated FDA recalls Z-0740-2016
  6. Listed FDA GUDID 03610230005613
  7. Recall initiated FDA recalls Z-0493-2018
  8. Recall initiated FDA recalls Z-0494-2018
  9. Registered EUDAMED B-03610230005613

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
Abx Pentra Reference 280ml
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Model / reference
A11A01901 EUDAMED
1220001901 GUDID
Primary DI / UDI-DI
03610230005613
Basic UDI-DI
B-03610230005613
510(k) Number
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
A11A01901
GUDID
1220001901
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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Cleared under the same submission (K052007)

and 8 more cleared under K052007

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Horiba Abx

See all devices from Horiba Abx →

Properties

  • Single use
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)