510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230092Unknown

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

DiaSorin Molecular LLC, Cypress CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230092 is the FDA 510(k) clearance record for Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390), a class II device, cleared for Diasorin Molecular, LLC on under FDA product code SBT (Device To Detect Microbial Colonization Directly From Clinical Specimens.). FDA's definition for product code SBT reads: "A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being...". FDA records list 32 510(k) clearances for Diasorin Molecular, LLC, from to . As of , FDA records show no recalls naming DEN230092.

Clearance record

Decision date
Received
(200 days to decision)
Product code
SBT Device To Detect Microbial Colonization Directly From Clinical Specimens.
Regulation
21 CFR 866.3967
Device class
Class II
Review panel
Microbiology
Applicant
Diasorin Molecular, LLC 11331 Valley View St., Cypress CA
Third party review
No

Clearances, product code SBT

Trailing 12 months

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

FDA records show no clearances under product code SBT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBT, 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