Cleared Traditional

K172509 - Sentosa SA201 HSV 1/2 Qualitative PCR Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172509 · Vela Diagnostics USA, Inc. · Microbiology device
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Feb 2018
Decision
164d
Days
Class 2
Risk

K172509 is an FDA 510(k) clearance for the Sentosa SA201 HSV 1/2 Qualitative PCR Test. Classified as Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO), Class II - Special Controls.

Submitted by Vela Diagnostics USA, Inc. (Fairfield, US). The FDA issued a Cleared decision on February 1, 2018 after a review of 164 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vela Diagnostics USA, Inc. devices

Submission Details

510(k) Number K172509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date February 01, 2018
Days to Decision 164 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 102d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.