Home / 510(k) Clearances / K170491

510(k) K170491

Solana C. difficile Assay by Quidel Corporation — Product Code OZN

K170491 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Solana C. difficile Assay". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Quidel Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2017
Date Received
February 17, 2017
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 Quidel Corporation

  • K231795 — QuickVue COVID-19 Test (March 22, 2024)
  • K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (December 20, 2023)
  • K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (December 13, 2023)
  • K230349 — Lyra RSV+hMPV Assay (March 10, 2023)
  • DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (March 8, 2023)
  • K230236 — Lyra Influenza A+B Assay (March 3, 2023)
  • K211342 — Sofia 2 Campylobacter FIA (November 23, 2021)
  • K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set (August 30, 2018)
  • K181029 — Solana Bordetella Complete Assay (July 15, 2018)
  • K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (February 28, 2018)

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)
  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
  • K142422 — cobas Cdiff Test (May 20, 2015)
  • K133936 — ARTUS C. DIFFICILE QS-RGQ MDX KIT (April 4, 2014)

FDA data resources