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Imx Ca 125

by Abbott Diagnostics

510(k) K964185

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964185 Date4 Nov 1997ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0322-04 FDA Unclassified (pre-2012) initiated 25 Nov 2003 on shared 510(k) K964185
    • Terminated Z-0320-04 FDA Unclassified (pre-2012) initiated 25 Nov 2003 on shared 510(k) K964185
    • Terminated Z-0318-04 FDA Unclassified (pre-2012) initiated 25 Nov 2003 on shared 510(k) K964185
    • Terminated Z-0319-04 FDA Unclassified (pre-2012) initiated 25 Nov 2003 on shared 510(k) K964185

    The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LTK
Device Class
Class II
Regulation
21 CFR Part 866.6010
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Imx Ca 125 is an epithelial ovarian tumor-associated antigen test. It is designed for use in clinical laboratory settings to detect the presence of the CA 125 antigen.

This device is classified as a Class 2 medical device under regulation number 866.6010. It has received FDA 510(k) clearance under the submission number K964185.

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