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Piccolo Hepatic Function Panel 400-0026

by Abaxis, Inc.

Piccolo Hepatic Function Panel 400-0026 is a Class II device made by Abaxis, Inc., cleared under FDA 510(k) K950164 on 13 Apr 1995 (2 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI EABA40000261), 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

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEABA40000261 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK950164 Date13 Apr 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K950164 decided 13 Apr 1995 Active· +2 more in the status table
  • FDA GUDID UDI-DI EABA40000261 listed 23 Sep 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2361-2020 FDA Class II initiated 11 Dec 2019 on shared 510(k) K934592

    Incorrect reference ranges of analytes.

    • Terminated Z-1066-2011 FDA Unclassified (pre-2012) initiated 19 Nov 2010

    Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer.

    • Terminated Z-1155-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009 on shared 510(k) K942782

    Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.

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

Timeline

7 dated events

  1. Cleared FDA 510(k) K934592
  2. Cleared FDA 510(k) K942782
  3. Cleared FDA 510(k) K950164
  4. Recall initiated FDA recalls Z-1155-2010
  5. Recall initiated FDA recalls Z-1066-2011
  6. Listed FDA GUDID EABA40000261
  7. Recall initiated FDA recalls Z-2361-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Piccolo Hepatic Function Panel
Generic name
Total alkaline phosphatase (ALP) IVD, reagent
Model / Ref / Catalog
400-0026
Primary DI / UDI-DI
EABA40000261
510(k) Number
FDA product code
CKF, CKA, CJW, CEK, CIG, CIT
GMDN term
Total alkaline phosphatase (ALP) IVD, reagent
Device class
Class II
Regulation number
862.1050, 862.1030, 862.1035, 862.1635, 862.1110, 862.1100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Alanine aminotransferase (ALT) IVD, reagentTotal aspartate aminotransferase (AST) IVD, reagentTotal protein IVD, reagentAlbumin IVD, reagent

Cleared under the same submission (K934592)

and 6 more cleared under K934592

Cleared under the same submission (K942782)

and 5 more cleared under K942782

Similar devices

Other devices filed under FDA product code CKA.

Other devices from Abaxis, Inc.

See all devices from Abaxis, Inc. →

Properties

  • Single use
  • Contains latex
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (10, all answered No)