510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K103798Substantially Equivalent

Bd Probetec Herpes Simplex Viruses (Hsv 1& 2) Q Amplified DNA Assays

Becton Dickinson & Co, Sparks MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103798 is the FDA 510(k) clearance record for BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS, a class II device, cleared for Becton, Dickinson & CO 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 345 510(k) clearances for Becton, Dickinson & CO, from to . As of , FDA records show no recalls naming K103798.

Clearance record

Decision date
Received
(81 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
Becton, Dickinson & CO 7loveton Cir., Sparks MD
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OQO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260