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510(k) K162673

Aptima Herpes Simplex Viruses 1 & 2 Assay by Hologic, Inc. — Product Code OQO

K162673 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima Herpes Simplex Viruses 1 & 2 Assay". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305. Hologic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
September 26, 2016
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 Hologic, Inc.

  • K254090 — I-View® (September 2, 2026)
  • K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) (August 12, 2026)
  • K253634 — CoolSeal Generator® (CSL-200-90) (June 17, 2026)
  • K251993 — Panther Fusion GI Expanded Bacterial Assay (September 25, 2025)
  • K251868 — Panther Fusion GI Bacterial Assay (September 25, 2025)
  • K243341 — Genius AI Detection 2.0 (July 31, 2025)
  • K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
  • K243935 — Aptima CMV Quant Assay (January 17, 2025)
  • K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
  • K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (November 15, 2024)

Other clearances for product code OQO

  • K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR Test (February 1, 2018)
  • 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)
  • K142738 — artus HSV-1/2 QS-RGQ MDx Kit (December 19, 2014)
  • 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