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510(k) K132235

IMDX C.DIFFICILE FOR ABBOTT M2000 by Intelligent Medical Devices, Inc. — Product Code OZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
July 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Toxin Gene Amplification Assay
Device Class
Class II
Regulation Number
866.3130
Review Panel
MI
Submission Type

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

Other clearances by Intelligent Medical Devices, Inc.

  • K140198 — IMDX HSV-1/2 FOR ABBOTT M2000 (May 13, 2014)
  • K131584 — IMDX FLU A/B AND RSV FOR ABBOTT M2000 (August 21, 2013)
  • K123753 — IMDX VANR FOR ABBOTT M2000 (July 17, 2013)

Other clearances for product code OZN

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  • K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2) (November 14, 2023)
  • K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System (October 20, 2021)
  • K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System (September 9, 2021)
  • K172569 — GenePOC CDiff (November 22, 2017)
  • K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System (September 12, 2017)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K170491 — Solana C. difficile Assay (May 11, 2017)
  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
  • K142422 — cobas Cdiff Test (May 20, 2015)