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Aptima Combo 2 Assay (Panther System)

by Hologic / Gen-Probe Incorporated

510(k) K132251

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132251 Date17 Oct 2013ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0595-2018 FDA Class II initiated 20 Jan 2018 on shared 510(k) K132251

    The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

    • Terminated Z-0027-2018 FDA Class II initiated 15 Sep 2017 on shared 510(k) K132251

    An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

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  • Withdrawn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
LSL
Device Class
Class II
Regulation
21 CFR Part 866.3390
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent