510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113433Substantially Equivalent

Simplexa C. Difficile Universal Direct

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113433 is the FDA 510(k) clearance record for SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT, a class I device, cleared for Focus Diagnostics, Inc. on under FDA product code OMN (C. Difficile Nucleic Acid Amplification Test Assay). FDA's definition for product code OMN reads: "In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients". FDA records list 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show no recalls naming K113433.

Clearance record

Decision date
Received
(135 days to decision)
Product code
OMN C. Difficile Nucleic Acid Amplification Test Assay
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Focus Diagnostics, Inc. 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMN

Trailing 12 months

FDA records hold no clearances under product code OMN in the trailing twelve months.

FDA records show no clearances under product code OMN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260