Cleared Traditional

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

K200506 · Chembio Diagnostic Systems · Microbiology
Jun 2020
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K200506 is an FDA 510(k) clearance for the DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader, a Zika Virus Serological Reagents (Class II — Special Controls, product code QFO), submitted by Chembio Diagnostic Systems (Medford, US). The FDA issued a Cleared decision on June 3, 2020, 93 days after receiving the submission on March 2, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3935.

Submission Details

510(k) Number K200506 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date June 03, 2020
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QFO — Zika Virus Serological Reagents
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3935
Definition 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.