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Architect 1P31-01

by Abbott

Ref 01P3101

Architect 1P31-01 (01P3101) is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 038074ARP0131NS), cleared under FDA 510(k) K102699 on 1 Apr 2011 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740001735), active as of 24 Oct 2026. One FDA recall is linked to it.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K102699

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/IVDR EUDAMED Number038074ARP0131NS Basic UDI-DI 00380740001735UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740001735 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK102699 Date1 Apr 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038074ARP0131NS registered 24 Aug 2026 Active
  • FDA 510(k) K102699 decided 1 Apr 2011 Active
  • FDA GUDID UDI-DI 00380740001735 listed 9 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2117-2020 FDA Class II initiated 24 Apr 2020

    Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.

Timeline

4 dated events

  1. Cleared FDA 510(k) K102699
  2. Listed FDA GUDID 00380740001735
  3. Recall initiated FDA recalls Z-2117-2020
  4. Registered EUDAMED 038074ARP0131NS

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Gentamicin therapeutic drug monitoring IVD, calibrator
Device name
Architect iGentamicin
Model / Ref / Catalog
01P3101, 1P31-01
Primary DI / UDI-DI
00380740001735
Basic UDI-DI
038074ARP0131NS
510(k) Number
FDA product code
LCD, DLJ
EMDN code
W0102152201 Tdm/drug standards and calibrators
GMDN term
Gentamicin therapeutic drug monitoring IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.3450, 862.3200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
01P3101
GUDID
1P31-01
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Gentamicin therapeutic drug monitoring IVD, calibrator

Cleared under the same submission (K102699)

Similar devices in this category

Other devices filed under TDM/DRUG STANDARDS AND CALIBRATORS.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)