Skip to content

i-STAT 03P92-25

by Abbott Point of Care Inc.

i-STAT 03P92-25 is a Class II device made by Abbott Point of Care Inc., cleared under FDA 510(k) K051433 on 15 Dec 2005 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 10054749000200), active as of 23 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

4 closed

Documents

510(k) K051433

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10054749000200 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK051433 Date15 Dec 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051433 decided 15 Dec 2005 Active
  • FDA GUDID UDI-DI 10054749000200 listed 9 Sep 2016 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0761-2020 FDA Class II initiated 16 Oct 2019 on shared 510(k) K051433

    i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.

    • Terminated Z-2171-2012 FDA Class II initiated 1 Feb 2012

    The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

  • 2 recalls, same reason

    • Terminated Z-0317-2011 FDA Unclassified (pre-2012) initiated 1 Jan 2008 on shared 510(k) K051433
    • Terminated Z-0318-2011 FDA Unclassified (pre-2012) initiated 1 Jan 2008 on shared 510(k) K051433

    i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K051433
  2. Recall initiated FDA recalls Z-0317-2011
  3. Recall initiated FDA recalls Z-0318-2011
  4. Recall initiated FDA recalls Z-2171-2012
  5. Listed FDA GUDID 10054749000200
  6. Recall initiated FDA recalls Z-0761-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
i-STAT
Generic name
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
Model / Ref / Catalog
03P92-25
Primary DI / UDI-DI
10054749000200
510(k) Number
FDA product code
MYT
GMDN term
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
Device class
Class II
Regulation number
862.1215
GUDID distribution status
In Commercial Distribution

Related devices

Category: Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent

Similar devices

Other devices filed under FDA product code MYT (BIOSENSOR, IMMUNOASSAY, CPK OR ISOENZYMES).

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains latex
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)