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Abbott Axsym System

by Abbott Laboratories 510(k)

Active United States

510(k) K974651

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974651 Date12 Feb 1998ClearedStatusActive

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
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

    • Terminated Z-2317-2009 FDA Unclassified (pre-2012) initiated 18 Feb 2009

    Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.

    • Terminated Z-0117-2007 FDA Unclassified (pre-2012) initiated 8 Sep 2006

    Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.

    • Terminated Z-0274-04 FDA Unclassified (pre-2012) initiated 29 Oct 2003

    Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.

    • Terminated Z-0421-03 FDA Unclassified (pre-2012) initiated 18 Dec 2002

    Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.

    • Terminated Z-0173-04 FDA Unclassified (pre-2012) initiated 6 Jun 2002

    Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.

Specification

510(k)

510(k) Number
FDA Product Code
JJE
Device Class
Class I
Regulation
21 CFR Part 862.2160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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