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510(k) DEN180069

ZIKV Detect 2.0 IgM Capture ELISA by InBios International, Inc. — Product Code QFO

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 23, 2019
Date Received
December 26, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Zika Virus Serological Reagents
Device Class
Class II
Regulation Number
866.3935
Review Panel
MI
Submission Type

Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.

Other clearances by InBios International, Inc.

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  • DEN220044 — Active Anthrax DetectTM Plus Rapid Test (February 3, 2023)
  • K181473 — DENV Detect NS1 ELISA (August 27, 2018)
  • K161947 — Chagas Detect Plus Rapid Test (December 16, 2016)
  • K141341 — CL DETECT RAPID TEST (November 14, 2014)

Other clearances for product code QFO

  • K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (June 3, 2020)
  • K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (October 28, 2019)
  • K191578 — ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika I (July 17, 2019)