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Pointe Scientific, Inc. H7546-CTL

by Horiba Instruments Incorporated

Pointe Scientific, Inc. H7546-CTL is a Class II device made by Horiba Instruments Incorporated, cleared under FDA 510(k) K952720 on 20 Sep 1995 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00811727014566), active as of 24 Oct 2026. 3 FDA recalls are 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

3 closed

Documents

510(k) K952720

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 Number00811727014566 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK952720 Date20 Sep 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K952720 decided 20 Sep 1995 Active
  • FDA GUDID UDI-DI 00811727014566 listed 31 Aug 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0349-2023 FDA Class III initiated 5 Oct 2021

    The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

    • Terminated Z-0350-2023 FDA Class III initiated 5 Oct 2021

    The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

    • Terminated Z-0131-06 FDA Unclassified (pre-2012) initiated 18 Aug 2005

    The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.

Timeline

5 dated events

  1. Cleared FDA 510(k) K952720
  2. Recall initiated FDA recalls Z-0131-06
  3. Listed FDA GUDID 00811727014566
  4. Recall initiated FDA recalls Z-0349-2023
  5. Recall initiated FDA recalls Z-0350-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pointe Scientific, Inc.
Generic name
Glycated haemoglobin (HbA1c) IVD, control
Model / Ref / Catalog
H7546-CTL
Primary DI / UDI-DI
00811727014566
510(k) Number
FDA product code
JPK
GMDN term
Glycated haemoglobin (HbA1c) IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, control

Similar devices in this category

Other devices filed under Glycated haemoglobin (HbA1c) IVD, control.

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Properties

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