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Piccolo Renal Function Panel 400-0027

by Abaxis, Inc.

Piccolo Renal Function Panel 400-0027 is a Class I device made by Abaxis, Inc., cleared under FDA 510(k) K022312 on 5 Sep 2002 (6 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI EABA40000271), 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 NumberEABA40000271 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK022312 Date5 Sep 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K022312 decided 5 Sep 2002 Active· +6 more in the status table
  • FDA GUDID UDI-DI EABA40000271 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

13 dated events

  1. Cleared FDA 510(k) K992140
  2. Cleared FDA 510(k) K993211
  3. Cleared FDA 510(k) K010670
  4. Cleared FDA 510(k) K022312
  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 EABA40000271
  10. Recall initiated FDA recalls Z-2361-2020

3 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 Renal Function Panel
Generic name
Inorganic phosphate (PO43-) IVD, reagent
Model / Ref / Catalog
400-0027
Primary DI / UDI-DI
EABA40000271
510(k) Number
FDA product code
CEO, CHJ, JGS, KHS, CEM, CJY, CDN, CGX, CJW, CGA
GMDN term
Inorganic phosphate (PO43-) IVD, reagent
Device class
Class I
Regulation number
862.1580, 862.1170, 862.1665, 862.1160, 862.1600, 862.1145, 862.1770, 862.1225, 862.1035, 862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose IVD, reagentInorganic phosphate (PO43-) IVD, reagentUrea IVD, reagentCreatinine IVD, reagent

Cleared under the same submission (K010670)

and 3 more cleared under K010670

Cleared under the same submission (K022312)

Similar devices

Other devices filed under FDA product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus).

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)