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510(k) K091109

XPERT C. DIFFICILE by Cepheid — Product Code LLH

K091109 is an FDA 510(k) premarket notification submitted by Cepheid for the device "XPERT C. DIFFICILE". The FDA issued a decision of Substantially Equivalent on July 9, 2009. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Cepheid has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2009
Date Received
April 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Clostridium Difficile Toxin
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Cepheid

  • K253653 — Xpert Hemorrhagic Fever (February 20, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K250218 — Xpert® FII & FV (February 21, 2025)
  • K242071 — Xpert Xpress CoV-2/Flu/RSV plus (January 10, 2025)
  • DEN240016 — Xpert HCV; GeneXpert Xpress System (June 27, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)

Other clearances for product code LLH

  • K193490 — SensiTox C. difficile Toxin Test (July 8, 2021)
  • K102242 — OSOM C. DIFFICILE TOXIN A/B TEST (December 21, 2010)
  • K090239 — PROGASTRO CD ASSAY (April 16, 2009)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K081920 — BD GENEOHM CDIFF ASSAY (December 19, 2008)
  • K080931 — VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (June 11, 2008)
  • K072138 — VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (December 21, 2007)
  • K050891 — TOX A/B QUICK CHEK (July 25, 2005)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050 (August 20, 2004)

FDA data resources