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510(k) K123197

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) by Nanosphere, Inc. — Product Code OZN

K123197 is an FDA 510(k) premarket notification submitted by Nanosphere, Inc. for the device "VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)". The FDA issued a decision of Substantially Equivalent on December 5, 2012. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Nanosphere, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2012
Date Received
October 11, 2012
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 Nanosphere, Inc.

  • K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (September 4, 2015)
  • K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (June 20, 2014)
  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)
  • K112424 — VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (December 16, 2011)
  • K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (January 10, 2011)
  • K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (November 17, 2009)
  • K092957 — VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (October 21, 2009)

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)
  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
  • K142422 — cobas Cdiff Test (May 20, 2015)

FDA data resources