510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K163085Substantially Equivalent

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163085 is the FDA 510(k) clearance record for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack, a class II device, cleared for Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC on under FDA product code OZN (C. Difficile Toxin Gene Amplification Assay). FDA's definition for product code OZN reads: "Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients". FDA records list one 510(k) clearance for Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. As of , FDA records show no recalls naming K163085.

Clearance record

Decision date
Received
(103 days to decision)
Product code
OZN C. Difficile Toxin Gene Amplification Assay
Regulation
21 CFR 866.3130
Device class
Class II
Review panel
Microbiology
Applicant
Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZN

Trailing 12 months
1 clearance under product code OZN in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OZN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260