510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172509Substantially Equivalent

Sentosa SA201 HSV 1/2 Qualitative PCR Test

Vela Diagnostics USA, Inc, Fairfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172509 is the FDA 510(k) clearance record for Sentosa SA201 HSV 1/2 Qualitative PCR Test, a class II device, cleared for Vela Diagnostics USA, Inc. 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 one 510(k) clearance for Vela Diagnostics USA, Inc. As of , FDA records show no recalls naming K172509.

Clearance record

Decision date
Received
(164 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
Vela Diagnostics USA, Inc. 353 C Us Rte. 46 W., Suite 250, Fairfield NJ
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