510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150962Substantially Equivalent

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

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

K150962 is the FDA 510(k) clearance record for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack, a class II device, cleared for Focus Diagnostics on under FDA product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay). FDA's definition for product code OQO reads: "A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens". FDA records list 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show 2 recalls naming K150962.

Clearance record

Decision date
Received
(140 days to decision)
Product code
OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Focus Diagnostics 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQO

Trailing 12 months

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

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