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Piccolo Basic Metabolic Panel Plus 400-0031

by Abaxis, Inc.

Piccolo Basic Metabolic Panel Plus 400-0031 is a Class II device made by Abaxis, Inc., cleared under FDA 510(k) K051108 on 8 Jul 2005 (7 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI EABA40000311), active as of 23 Oct 2026.

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

5 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEABA40000311 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK051108 Date8 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051108 decided 8 Jul 2005 Active· +7 more in the status table
  • FDA GUDID UDI-DI EABA40000311 listed 23 Sep 2016 Listed

Recalls

5 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 on shared 510(k) K950164

    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.

  • 2 recalls, same reason

    • Terminated Z-2286-2008 FDA Unclassified (pre-2012) initiated 21 Apr 2008 on shared 510(k) K992140
    • Terminated Z-2287-2008 FDA Unclassified (pre-2012) initiated 21 Apr 2008 on shared 510(k) K992140

    The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples

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

Timeline

14 dated events

  1. Cleared FDA 510(k) K993211
  2. Cleared FDA 510(k) K010670
  3. Cleared FDA 510(k) K040115
  4. Cleared FDA 510(k) K051108
  5. Recall initiated FDA recalls Z-2286-2008
  6. Recall initiated FDA recalls Z-2287-2008
  7. Recall initiated FDA recalls Z-1155-2010
  8. Recall initiated FDA recalls Z-1066-2011
  9. Listed FDA GUDID EABA40000311
  10. Recall initiated FDA recalls Z-2361-2020

4 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Piccolo Basic Metabolic Panel Plus
Generic name
Total lactate dehydrogenase (LDH) IVD, reagent
Model / Ref / Catalog
400-0031
Primary DI / UDI-DI
EABA40000311
510(k) Number
FDA product code
CFJ, JGJ, CHJ, JGS, KHS, CEM, CJY, CDN, CGX, CGA
GMDN term
Total lactate dehydrogenase (LDH) IVD, reagent
Device class
Class II
Regulation number
862.1440, 862.1495, 862.1170, 862.1665, 862.1160, 862.1600, 862.1145, 862.1770, 862.1225, 862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose IVD, reagentUrea IVD, reagentCreatinine IVD, reagentCalcium (Ca2+) IVD, reagent

Cleared under the same submission (K010670)

and 3 more cleared under K010670

Cleared under the same submission (K040115)

Similar devices

Other devices filed under FDA product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase).

Other devices from Abaxis, Inc.

See all devices from Abaxis, Inc. →

Properties

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