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510(k) K172509

Sentosa SA201 HSV 1/2 Qualitative PCR Test by Vela Diagnostics USA, Inc. — Product Code OQO

K172509 is an FDA 510(k) premarket notification submitted by Vela Diagnostics USA, Inc. for the device "Sentosa SA201 HSV 1/2 Qualitative PCR Test". The FDA issued a decision of Substantially Equivalent on February 1, 2018. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2018
Date Received
August 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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.

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  • K111951 — ISOAMP HSV ASSAY (September 27, 2011)
  • K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (August 3, 2011)
  • K103798 — BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS (March 18, 2011)

FDA data resources