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Pointe G6PD Controls G7583-CTL

by Horiba Instruments Incorporated

Pointe G6PD Controls G7583-CTL is a Class II device made by Horiba Instruments Incorporated, cleared under FDA 510(k) K024006 on 31 Mar 2003 and listed in FDA GUDID since 30 Jan 2021 (UDI-DI 00811727015679), active as of 24 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K024006

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811727015679 UDI-DI Date30 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024006 Date31 Mar 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024006 decided 31 Mar 2003 Active
  • FDA GUDID UDI-DI 00811727015679 listed 30 Jan 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-2487-2015 FDA Class II initiated 19 May 2015

    A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set.

Timeline

3 dated events

  1. Cleared FDA 510(k) K024006
  2. Recall initiated FDA recalls Z-2487-2015
  3. Listed FDA GUDID 00811727015679

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pointe G6PD Controls
Generic name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Model / Ref / Catalog
G7583-CTL
Primary DI / UDI-DI
00811727015679
510(k) Number
FDA product code
JBF
GMDN term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Device class
Class II
Regulation number
864.7360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

Cleared under the same submission (K024006)

Similar devices

Other devices filed under FDA product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening).

Other devices from Horiba Instruments Incorporated

See all devices from Horiba Instruments Incorporated →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)