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Axsym Total B-Hcg

by Abbott Laboratories 510(k)

Active United States

510(k) K935673

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935673 Date21 Jun 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
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  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

7 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1070-2007 FDA Unclassified (pre-2012) initiated 10 Apr 2007
    • Terminated Z-1067-2007 FDA Unclassified (pre-2012) initiated 10 Apr 2007
    • Terminated Z-1068-2007 FDA Unclassified (pre-2012) initiated 10 Apr 2007
    • Terminated Z-1069-2007 FDA Unclassified (pre-2012) initiated 10 Apr 2007

    An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.

    • Terminated Z-0893-05 FDA Unclassified (pre-2012) initiated 24 Mar 2005

    Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.

    • Terminated Z-0006-05 FDA Unclassified (pre-2012) initiated 24 Aug 2004

    Assay may give elevated patients results.

    • Terminated Z-1436-04 FDA Unclassified (pre-2012) initiated 7 Jul 2004

    Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.

Specification

510(k)

510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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