Cleared Traditional

K191578 - 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 (FDA 510(k) Clearance)

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

K191578 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Jul 2019
Decision
33d
Days
Class 2
Risk

K191578 is an FDA 510(k) clearance for the ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zik.... Classified as Zika Virus Serological Reagents (product code QFO), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 17, 2019 after a review of 33 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K191578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date July 17, 2019
Days to Decision 33 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 102d · This submission: 33d
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.