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IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS

by Beckman Coulter Ireland Inc.

Ref 800-7702

IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS (800-7702) is a multiple urine analyte IVD (EU IVDD general IVD; FDA Class I; FDA product code JJW, Urinalysis Controls (Assayed And Unassayed)) made by Beckman Coulter Ireland Inc., registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI B-10837461002680), cleared under FDA 510(k) K072640 on 21 Dec 2007 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 10837461002680), active as of 23 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) K072640

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10837461002680 Basic UDI-DI 10837461002680UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10837461002680 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK072640 Date21 Dec 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10837461002680 registered 11 Sep 2026 Active
  • FDA 510(k) K072640 decided 21 Dec 2007 Active
  • FDA GUDID UDI-DI 10837461002680 listed 7 Sep 2016 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

    • Ongoing Z-0093-2025 FDA Class III initiated 16 Jul 2024

    Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

    • Ongoing Z-0777-2023 FDA Class II initiated 18 Nov 2022

    Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

Timeline

5 dated events

  1. Cleared FDA 510(k) K072640
  2. Listed FDA GUDID 10837461002680
  3. Recall initiated FDA recalls Z-0777-2023
  4. Recall initiated FDA recalls Z-0093-2025
  5. Registered EUDAMED B-10837461002680

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
IRISpec CA/CB/CC Urine Chemistry Controls EUDAMED
IRISpec GUDID
Generic name
Multiple urine analyte IVD, control
Model / Ref / Catalog
800-7702, CA/CB/CC URINE CHEMSITRY CONTROLS
Primary DI / UDI-DI
10837461002680
Basic UDI-DI
B-10837461002680
510(k) Number
FDA product code
JJW
EMDN code
W01010999 Multiple parameters urine testing - other
GMDN term
Multiple urine 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
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
800-7702
GUDID
CA/CB/CC URINE CHEMSITRY CONTROLS
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 urine analyte IVD, control

Cleared under the same submission (K072640)

Similar devices in this category

Other devices filed under MULTIPLE PARAMETERS URINE TESTING - OTHER.

Other devices from Beckman Coulter Ireland Inc.

See all devices from Beckman Coulter Ireland Inc. →

Properties

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