Home / 510(k) Clearances / K150617

510(k) K150617

cobas HSV 1 and 2 Test by Roche Molecular Systems, Inc. — Product Code OQO

K150617 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas HSV 1 and 2 Test". The FDA issued a decision of Substantially Equivalent on June 1, 2015. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2015
Date Received
March 10, 2015
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 Roche Molecular Systems, Inc.

  • K260021 — cobas® BV/CV (July 16, 2026)
  • K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on (July 8, 2026)
  • K253756 — cobas liat CT/NG nucleic acid test (May 15, 2026)
  • K253759 — cobas liat CT/NG/MG nucleic acid test (May 15, 2026)
  • K243753 — cobas liat Bordetella panel nucleic acid test (November 20, 2025)
  • K252481 — cobas CMV (November 3, 2025)
  • K252484 — cobas HCV (November 3, 2025)
  • K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (July 31, 2025)
  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)

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)
  • 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