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510(k) K142738

artus HSV-1/2 QS-RGQ MDx Kit by Qiagen — Product Code OQO

K142738 is an FDA 510(k) premarket notification submitted by Qiagen for the device "artus HSV-1/2 QS-RGQ MDx Kit". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305. Qiagen has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
September 23, 2014
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.

Other clearances by Qiagen

  • K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx (March 9, 2026)
  • K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx (October 22, 2025)
  • K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (August 27, 2025)
  • K250324 — QIAstat-Dx GI Panel 2 Mini B (February 28, 2025)
  • K243813 — QIAstat-Dx GI Panel 2 Mini B&V (January 8, 2025)
  • K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel (October 29, 2024)
  • K242353 — QIAstat-Dx Respiratory Panel Mini (October 25, 2024)
  • K220062 — QIAstat-Dx Gastrointestinal Panel 2 (May 31, 2024)
  • K233100 — QIAstat-Dx® Respiratory Panel Plus (May 10, 2024)
  • K183597 — QIAstat-Dx Respiratory Panel (May 18, 2019)

Other clearances for product code OQO

  • K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR Test (February 1, 2018)
  • K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay (June 15, 2017)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • K150617 — cobas HSV 1 and 2 Test (June 1, 2015)
  • K142156 — SEEGENE ANYPLEX II HSV-1/2 ASSAY (February 13, 2015)
  • K140198 — IMDX HSV-1/2 FOR ABBOTT M2000 (May 13, 2014)
  • K140029 — AMIPLIVUE HSV 1&2 ASSAY (March 26, 2014)
  • 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