510(k) · Cleared

Cleared

Sentosa SA201 HSV 1/2 Qualitative PCR Test

K172509510(k) TraditionalCleared Feb 1, 2018164-day reviewClass II21 CFR 866.3305

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vela Diagnostics USA, Inc. · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

Cleared on Feb 1, 2018 as substantially equivalent to K140198 (Intelligent Medical Devices, Inc., 2014) after a 164-day review. Its family tree reaches back 3 generations to 1997.

Decided: Feb 1, 2018
Review: 164 days
Class: Class II
Product code: OQO
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K971662 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
2 generations backK100336 Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010
1 generation backK140198 Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014
This deviceK172509 Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K971662	Elvis HSV ID/Typing Test System	Diagnostic Hybrids, Inc.	1997	—
−2	K100336	Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711	Eragen Biosciences	2010	—
−1	K140198	Imdx HSV-1/2 for Abbott M2000	Intelligent Medical Devices, Inc.	2014	—
0 (this device)	K172509	Sentosa SA201 HSV 1/2 Qualitative PCR Test	Vela Diagnostics USA, Inc.	2018	—

FIG. 1 — Lineage of K172509, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K140198	Imdx HSV-1/2 for Abbott M2000 Summary page 4 …distribution: Trade Name: IMDx HSV-1/2 for Abbott m2000 Assay Common Name: Herpes Simplex Virus Nucleic Acid Amplification Assay 510(k) Number: K140198 (cleared 05/13/2014) Manufacturer: Intelligent Medical Devices, Inc. 510(k): Sentosa® SA201 HSV-1/2 PCR Test…	Intelligent Medical Devices, Inc.	2014	—

Also cleared against K140198: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K140198.

How does its category compare?

All OQO devices

OQO Herpes Simplex Virus Nucleic Acid Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OQO

1in 2018

2007high 3 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQO

140in 2015

2007high 140 (2015) · low 81 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OQO

No recall names OQO since 2007.

Adverse event reports per year · OQO

1in 2025

2007high 6 (2016) · low 0 (2007)2025

MAUDE reports naming product code OQO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	3	81	0
2012	0	—	0
2013	0	—	0
2014	3	87	0
2015	3	140	0
2016	0	—	6
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	2
2025	0	—	1
2026	0	—	—

What is it indicated for?

The Sentosa® SA201 HSV-l/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test

for detection and differentiation of Herpes Simplex Virus (HSV-l and HSV-2) DNA from male and

female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of

herpes infection in symptomatic patients.

Warning: The Sentosa® SA201 HSV-l/2 PCR Test is not FDA cleared for use with cerebrospinal

fluid (CSF). The test is not intended to be used for prenatal screening.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K172509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172509: Sentosa SA201 HSV 1/2 Qualitative PCR Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172509

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026