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510(k) K140198

IMDX HSV-1/2 FOR ABBOTT M2000 by Intelligent Medical Devices, Inc. — Product Code OQO

K140198 is an FDA 510(k) premarket notification submitted by Intelligent Medical Devices, Inc. for the device "IMDX HSV-1/2 FOR ABBOTT M2000". The FDA issued a decision of Substantially Equivalent on May 13, 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. Intelligent Medical Devices, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2014
Date Received
January 27, 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 Intelligent Medical Devices, Inc.

  • K132235 — IMDX C.DIFFICILE FOR ABBOTT M2000 (October 11, 2013)
  • K131584 — IMDX FLU A/B AND RSV FOR ABBOTT M2000 (August 21, 2013)
  • K123753 — IMDX VANR FOR ABBOTT M2000 (July 17, 2013)

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)
  • K142738 — artus HSV-1/2 QS-RGQ MDx Kit (December 19, 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