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510(k) K200506

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader by Chembio Diagnostic Systems — Product Code QFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2020
Date Received
March 2, 2020
Clearance Type
Traditional
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 Chembio Diagnostic Systems

  • K011551 — SURE CHECK PREGNANCY TEST (August 14, 2001)
  • K011550 — HCG STAT PAK ULTRA-FAST (August 14, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K981913 — PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (February 12, 1999)
  • K961965 — SURE CHECK PREGNANCY TEST (June 24, 1996)
  • K923925 — HCG STAT-PAK (December 24, 1992)

Other clearances for product code QFO

  • 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)
  • DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA (May 23, 2019)