510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120413Substantially Equivalent

Simplexa Flu A/b & Rsv Direct, Simplexa Flu A/b & Rsv Positive Control Pack

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

K120413 is the FDA 510(k) clearance record for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK, a class II device, cleared for Focus Diagnostics, Inc. on under FDA product code OCC (Respiratory Virus Panel Nucleic Acid Assay System). FDA's definition for product code OCC reads: "A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The...". FDA records list 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show 2 recalls naming K120413.

Clearance record

Decision date
Received
(154 days to decision)
Product code
OCC Respiratory Virus Panel Nucleic Acid Assay System
Regulation
21 CFR 866.3980
Device class
Class II
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 OCC

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