Hybrid Capture II CT-Id Test

• • Terminated Z-0657-03 FDA Unclassified (pre-2012) ·initiated 7 Feb 2003 ·on shared 510(k) K990023

  In Vitro diagnostic test kit may produce false positive patient results

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

510(k) Number

K990023 ↗

FDA Product Code

LSK

Device Class

Class I

Regulation

21 CFR Part 866.3120

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Hybrid Capture System Cmv DNA Assay

  Class II

  FDA 510(k) K974901 Active Cleared 29 Sep 1998

• Hybrid Capture II Gc-Id

  Class II

  FDA 510(k) K981485 Active Cleared 29 Nov 1999

• Digene Dml 2000 Microplate Luminometer

  Class I

  FDA 510(k) K980120 Active Cleared 6 Feb 1998

• Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01

  Class II

  FDA 510(k) K010893 Active Cleared 24 Sep 2001

• Digene Cervical Brush

  Class II

  FDA 510(k) K971586 Active Cleared 19 Sep 1997

• Modification to Hybrid Capture II CT/Gc Test, Model 03M90-01

  Class I

  FDA 510(k) K010891 Active Cleared 25 Sep 2001

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