Gen-Probe Aptima Combo 2 Assay

• • Terminated Z-1793-2014 FDA Class III ·initiated 17 Apr 2014 ·on shared 510(k) K003395

  Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."

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

510(k) Number

K003395 ↗

FDA Product Code

LSL

FDA applicant

Gen-Probe, Inc.

Device Class

Class II

Regulation

21 CFR Part 866.3390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Pace 2 System for Chlamydia Trachomatis

  Class I

  FDA 510(k) K920378 Active Cleared 29 Apr 1992

• Accuprobe Mycobacterium Tuberculosis Complex Test

  Class I

  FDA 510(k) K896493 Active Cleared 11 Apr 1990

• Accuprobe Mycobacterium Gordonae Culture Test

  Class I

  FDA 510(k) K896492 Active Cleared 16 Apr 1990

• Gen-Probe Aptima Assay for Neisseria Gonorrhoeae

  Class II

  FDA 510(k) K043144 Active Cleared 14 Mar 2005

• Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199

  Class I

  FDA 510(k) K063451 Active Cleared 22 Jan 2007

• Tigris Dts Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196

  Class II

  FDA 510(k) K061509 Active Cleared 4 Oct 2006

See all devices from Gen-Probe →