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510(k) K181436

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test by SEKISUI Diagnostics, LLC — Product Code KTN

K181436 is an FDA 510(k) premarket notification submitted by SEKISUI Diagnostics, LLC for the device "OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test". The FDA issued a decision of Substantially Equivalent on June 22, 2018. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. SEKISUI Diagnostics, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2018
Date Received
June 1, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Infectious Mononucleosis
Device Class
Class II
Regulation Number
866.5640
Review Panel
MI
Submission Type

Other clearances by SEKISUI Diagnostics, LLC

  • K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System (April 18, 2025)
  • K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
  • K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)

Other clearances for product code KTN

  • K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (February 28, 2005)
  • K030215 — BIORAPID MONONUCLEOSIS (February 24, 2003)
  • K012901 — COLOR-MONOGEN (September 27, 2001)
  • K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (January 28, 1999)
  • K981946 — CLEARVIEW IM (December 10, 1998)
  • K972457 — MONOCOL/LEX-IM TEST (December 1, 1997)
  • K972231 — OSOM MONO TEST 143 (August 26, 1997)
  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (February 25, 1997)
  • K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (February 4, 1997)
  • K961550 — QUALITROL MONO CONTROL SERUM SET (September 24, 1996)

FDA data resources