Cleared Traditional

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K200506 is an FDA 510(k) clearance for the DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. Classified as Zika Virus Serological Reagents (product code QFO), Class II - Special Controls.

Submitted by Chembio Diagnostic Systems (Medford, US). The FDA issued a Cleared decision on June 3, 2020 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3935 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chembio Diagnostic Systems devices

Submission Details

510(k) Number K200506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFO Zika Virus Serological Reagents
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QFO Zika Virus Serological Reagents

Devices cleared under the same product code (QFO) and FDA review panel - the closest regulatory comparables to K200506.
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046 · DiaSorin, Inc. · Oct 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
K191578 · Siemens Healthcare Diagnostics, Inc. · Jul 2019
ZIKV Detect 2.0 IgM Capture ELISA
DEN180069 · InBios International, Inc. · May 2019