Home / 510(k) Clearances / K163085

510(k) K163085

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC — Product Code OZN

K163085 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC for the device "Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack". The FDA issued a decision of Substantially Equivalent on February 14, 2017. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2017
Date Received
November 3, 2016
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 for product code OZN

  • K243730 — Xpert C. difficile/Epi (February 28, 2025)
  • 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)
  • K142422 — cobas Cdiff Test (May 20, 2015)
  • K133936 — ARTUS C. DIFFICILE QS-RGQ MDX KIT (April 4, 2014)

FDA data resources